Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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December 22, 2004
04-51

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Baskin Robbins ice cream sold in 1 quart containers with lids that
identify the product as Chocolate Chip Cookie Dough and cups that identify the product as Oreo Cookies and Cream. Recall # F-096-5.
CODE
Code on the bottom of the container: MFG29JUL04 EXP28JUL05 7983 06-2238 with Lots 1 through 11 hh:mm.
RECALLING FIRM/MANUFACTURER
Alta-Dena Certified Dairy, City Of Industry, CA, by telephone and letters beginning on September 20, 2004. Firm initiated recall is complete.
REASON
Misbranded ice cream contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
1,880 cases (15,040 units).
DISTRIBUTION
AK, AZ, CA, NV, and UT.

_______________________________
PRODUCT
Packages labeled as: Dippin Stix Sliced Apples and Caramel, Keep Refrigerated NET WT. 4.25 oz. (120 g). Recall # F-097-5.
CODE
USE BY 11/20/04.
RECALLING FIRM/MANUFACTURER
Reichel Foods, LLC, Rochester, MN, by telephone on beginning on October 25, 2004. Firm initiated recall is ongoing.
REASON
Containers labeled as Sliced Apples and Caramel actually contained Sliced Apples and Peanut Butter with peanuts as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
80 cases.
DISTRIBUTION
TX.

_______________________________
PRODUCT
The Jelly Candy Factory brand Jelly Candy Pops Sour Zip Kids, Net Wt. 12 x 1 oz. Product consists of box containing 12 Halloween decorated jelly pops. Recall # F-098-5.
CODE
Item number 34712, no date code, no batch number.
RECALLING FIRM/MANUFACTURER
Morris National Inc, Azusa, CA, by telephone on October 28, 2004, email on October 29, 2004, and press release on November 4, 2004. Firm initiated recall is ongoing.
REASON
The product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
2,000 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Kroger Pecan Pieces packaged in 16 ounce size bags, UPC/NDC #1111073791. Recall # F-099-5.
CODE
Sell by date: May 23 05.
RECALLING FIRM/MANUFACTURER
Kroger Co, Cincinnati, OH, by e-mail on October 18, 2004. Firm
initiated recall is ongoing.
REASON
Packages labeled as ìPecan Piecesî actually contain walnut pieces.
VOLUME OF PRODUCT IN COMMERCE
2088 cases, each case containing 12/16 ounce packages.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
a) American Beauty Shel-Roni 16 oz plastic bag.
Item UPC number 26800-00266. The product is
shipped in cases containing 12 units.
Recall # F-100-5;
b) American Beauty Large Shel-Roni 16 oz and
24 oz plastic bags. Item UPC number for the
16 oz bag is 26800-00315. Item UPC number for
the 24 oz bag is 26800-00318. The products are
shipped in cases containing 12 units.
Recall # F-101-5;
c) American Beauty Roni Mac (Large Elbow) 16 oz and
24 oz plastic bags. Item UPC number for the
16 oz bags is 26800-00244. Item UPC number for
the 24 oz bags is 26800-00246. The 16 oz bags
are also sold under the Albertsonís brand label,
UPC number 41163-47241 and the Stater Brother
label, UPC number 74175-01765. The products are
shipped in cases containing 12 units.
Recall # F-102-5;
d) American Beauty Elbow Roni 24 oz plastic bag,
Item UPC number 26800-00208. The product is
shipped in cases containing 12 units.
Recall # F-103-5;
e) Albertsonís Small Sea Shells 16 oz plastic bag,
Item UPC number 41163-47264. The product is
shipped in cases containing 12 units.
Recall # F-104-5.
CODE
a) Code Date 4161F;
b) Code dates 4166F and 4167F;
c) Code dates American Beauty are 4168F and 4169F.
Best by Jun0906F for the Albertsonís label.
Best by Jun1706-F for the Stater Brothers label;
d) Code dates 4169F;
e) Best by Jun906F.
RECALLING FIRM/MANUFACTURER
New World Pasta, Harrisburg, PA, by press release and telephone on October 20, 2004. Firm initiated recall is ongoing.
REASON
The products may contain small metal shavings.
VOLUME OF PRODUCT IN COMMERCE
16,522 cases.
DISTRIBUTION
AZ, CA, ID, MT, NV, OR, UT, and WA.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
John Frieda, Frizz Ease 5-Minute Manager Blow Dryer Styling Spray in 6.7 oz. (200mL) plastic bottle with pump sprayer, packaged 6 bottles per case. Recall # F-106-5.
CODE
Lot #S025AS064 ‚ manufactured on 3/4/2004 and Lot #S025AS065 ‚ manufactured on 3/5/2004.
RECALLING FIRM/MANUFACTURER
Andrew Jergens Co., Cincinnati, OH, by letter dated August 2, 2004
and by press release on August 12, 2004. Firm initiated recall is
ongoing.
REASON
Product is contaminated with yeast and mold.
VOLUME OF PRODUCT IN COMMERCE
1,570 cases.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

_______________________________
PRODUCT
Twice-a-Day 12 HOUR NASAL SPRAY (oxymetazoline hydrocholoride 0.05%), sold in 1/2 FL. OZ (14.8mL) and 1 FL. OZ. (30mL) bottles, MAJOR brand, Regular, NASAL DECONGESTANT, --- NDC 0904-5217-35 -- Also sold under other name brand as: DU brand Nasal Spray Atomizador, Maximum Strength, Nasal Decongestant Spray. Recall # D-227-4.
CODE
Lots sold under MAJOR brand: K4496, A4588, L4535, E4410, F4433, H4464, L4529, M4536, A4558 and B459. Lot sold under DU brand: J4492.
RECALLING FIRM/MANUFACTURER
Propharma, Inc., Miami, FL, by press releases on March 18, 2004 and May 14, 2004. Firm initiated recall is ongoing.
REASON
Microbial Contamination; Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
416,677
DISTRIBUTION
Nationwide and PR.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Noveon CA-1 (calcium polycarbonphil) Bulk Active Pharmaceutical Ingredient, 100 kg fiber board drums. Recall # D-063-5.
CODE
Lot code No: TD44HD1756, TD44HD1758, TD44HD1759, TD44HD1760, TD44HD1761, TD44HD1762, TD44HD1763, TD44HD1764, TD44HD1765, TD44HD1766, TD45HD1767, TD45HD1768, TD45HD1769, TD45HD1770, TD45HD1771, TD45HD1772, TD45HD1773, TD45HD1774, TD45HD1775, TD45HD1776, TD45HD1777, TD45HD1778, TD45HD1779, TD45HD1780, TD45HD1781, TD46HD1783, TD46HD1784, TD46HD1785, TD46HD1786, TD46HD1787, TD46HD1789, TD46HD1790, TD46HD1791, TD46HD1792, TD46HD1793, TD46HD1797, TD47HD1798, TD47HD1799.
RECALLING FIRM/MANUFACTURER
Noveon Inc., Cleveland, OH, by letter on September 10, 2004. Firm initiated recall is ongoing.
REASON
Contamination with small latex glove pieces.
VOLUME OF PRODUCT IN COMMERCE
683/100 kg. Drums.
DISTRIBUTION
NJ, CT, and MI.

_______________________________
PRODUCT
RU-21 Tablets Dietary Supplement, 20 count blister packages. Recall # D-066-5.
CODE
Lot numbers: 12/02, 03/03, 10/03, 11/03, 02/04.
RECALLING FIRM/MANUFACTURER
Spirit Sciences USA, Inc., Beverly Hills, CA, by internet. Firm initiated recall is ongoing.
REASON
Unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
382,464 blister packages.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/vial) 60 x 2.5 mL Unit-Dose Vials (12 vials per foil pouch), For Oral Inhalation Only, Rx Only, NDC 0472-0753-60. Recall # D-068-5.
CODE
Lot A4B031 EXP 02/06.
RECALLING FIRM/MANUFACTURER
Alpharma USPD, Baltimore, MD, by letter on November 18, 2004.
REASON
Exceeds impurity specification (terephthalic acid).
VOLUME OF PRODUCT IN COMMERCE
176,400 vials.
DISTRIBUTION
NY.

_______________________________
PRODUCT
ONCASPAR Pegaspargase (PEG-L-asparaginase), 750 I.U. per mL, one 5.0 mL single dose vial, Sterile, for intrasmuscular use only, contains no preservative, Rx only, NDC 57665-002-02. Recall # D-069-5.
CODE
Lot AB0303, Exp. 2/25/05; Lot AK0332, Exp. 1/7/06.
RECALLING FIRM/MANUFACTURER
Enzon Pharmaceuticals, Inc., South Plainfield, NJ, by letters on
October 13, 2004. Firm initiated recall is ongoing.
REASON
Superpotent; product exceeds in-vitro enzyme levels (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
4,105 vials.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
ADVAIR DISKUS 100/50mcg (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder), 60 Doses per unit, For Oral Inhalation Only, Rx only, NDC 0173-0695-00. Recall # D-071-5.
CODE
Lot #B133672/Expiration Date: 7/2005.
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline, Inc., Zebulon, NC, by letter on November 22, 2004. Firm initiated recall is ongoing.
REASON
Defective container; patients may not receive medication as it is advanced through the Diskus unit.
VOLUME OF PRODUCT IN COMMERCE
19,120 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0338-5.
CODE
Unit 7157494 (split product).
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA, by telephone and by facsimile dated August 8, 2003. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for a leukocyte reduced product but was labeled as leukoreduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0340-5.
CODE
Unit numbers 02GWIF6657 and 02GWIF8108.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Green Bay, WI, by facsimile on March 31, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor whose routine physical examination was inadequately documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall B-0341-5.
CODE
Unit KC59412.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA, by letter dated June 25, 2004. Firm initiated recall is completed.
REASON
Blood product, corresponding to a unit of plasma that was hemolyzed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0345-5;
b) Fresh Frozen Plasma. Recall # B-0346-5;
c) Platelets for further manufacture. Recall # B-0347-5.
CODE
a), b), and c) Unit number 2045871.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE, by facsimile on August 9, 2004, and by letter on September 14, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
DE, and NJ.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0353-5.
CODE
Unit number 9076067.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE, by telephone on July 24, 2004, and by letter on September 7, 2004. Firm initiated recall is complete.
REASON
Blood product, that was not tested for pH as required by the firmís specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
DE.

_______________________________
PRODUCT
Source Plasma. Recall B-0354-5.
CODE
Unit numbers 02GWID4417, 02GWIF1798, 02GWID5096, 02GWID9113, 02GWID9790, 02GWIE1924, 02GWIE2598, 02GWIF1167, 02GWID6021, 02GWID6685, 02GWID7577, 02GWID8245, 02GWIE0737, 02GWIE1351, 02GWIE3445, 02GWIE4162, 02GWIE5014, 02GWIE5674, 02GWIE6534, 02GWIE7206, 02GWIE8090, 02GWIE8778, 02GWIE9664, 02GWIF0317, and 02GWIF2576.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Green Bay, WI, by facsimile on February 23, 2004. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
25 units.
DISTRIBUTION
CA, and Austria.

_______________________________
PRODUCT
Source Plasma. Recall B-0355-5.
CODE
Unit numbers 03GWIA5967, 03GWIA6818, 03GWIA9816, 03GWIB2809, 03GWIB5853, 03GWIC0294, 03GWID4754, 03GWIB4448, 03GWIB6571, 03GWIB7421, 03GWIC3313, 03GWIC5003, 03GWID0105, 03GWID0981, 03GWID1594, 03GWID2480, 03GWID3156, 03GWID4054, 03GWID6241, 03GWID7087, 03GWID7768, 03GWID8744, 03GWID9280, 03GWIE0571, 03GWIE2079, 03GWIE2908, 03GWIE3601, 03GWIE5125, 03GWIE6079, 03GWIE6793, and 03GWIE7671.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Green Bay, WI, by facsimile on
October 2, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor whose routine physical examination was inadequately documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units.
DISTRIBUTION
CA, and Austria.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0356-5.
CODE
Unit number 13P89758.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on July 4, 2004, and by letters dated July 23, 2004, and August 23, 2004. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was collected on an apheresis device undergoing validation and was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets. Recall # B-0382-5.
CODE
nit 0602748.
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by letter dated June 23, 2004.
Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated red blood cells was found to contain clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Source Plasma. Recall # B-0383-5.
CODE
Unit 03OWIC0313.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Oshkosh, WI, by letter dated May 8, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Source Plasma. Recall # B-0384-5.
CODE
Unit 02OWIF0474.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Oshkosh, WI, by facsimile and letter dated October 2, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose suitability was not adequately determined for risk factors for Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-0386-5.
CODE
Units 02GWIE4630, 02GWIE7096, 02GWIE8241, 02GWIE8944, 02GWIE4922, 02GWIE5585, and 02GWIE6316.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Green Bay, WI, by letter dated September 10, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability for risk factors for Creutzfeldt-Jakob Disease (CJD) were not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
Recall # B-0388-5;
b) Red Blood Cells Leukocytes Reduced
Irradiated. Recall # B-0389-5.
CODE
a) Units 102951014, 102951019, 102951034,
102951035, 102951087, 102951156,
102954685, 102954746, 102955945,
102955953, 102955982, 102956025,
102956032, 102956035, 102956065,
102956081, 102956086, 102956103,
102956116, 102956121, 102956131,
102960028, 102960047, 102960097,
102960113, 102960132, 102960181,
102964583, 102964585, 102964588,
102978801, 102978807, 102978870,
102978885, 102978930, 102978977,
102978981, 102978998, 102982471,
and 102982479;
b) Units 102955945 and 102956131.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on August 31, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
42 units.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0391-5.
CODE
Unit 107589332 (split unit).
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter on September 27, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units,
DISTRIBUTION
AZ.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0315-5;
b) Cryoprecipitated AHF. Recall # B-0316-5;
c) Recovered Plasma. Recall # B-0317-5.
CODE
a), b), and c) Unit 6277903.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated November 18, 2003.
Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, and Switzerland.

_______________________________
PRODUCT
a) Platelets. Recall # B-0336-5;
b) Fresh Frozen Plasma. Recall # B-0337-5.
CODE
a) and b) Unit number 6725887.
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on May 16, 2003, and by letter on May 20, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from a unit of Whole Blood that had a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ, and NY.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0348-5;
b) Cryoprecipitated AHF. Recall # B-0349-5;
c) Plasma, Cryoprecipitate Reduced.
Recall # B-0350-5.
CODE
a), b), and c) Unit number 1612234.
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by facsimile and letter on April 1, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of Idiopathic Thrombocytopenic Purpura (ITP), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NJ, CA, and TN.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0351-5.
CODE
Unit numbers 19242-7922, 19242-7932, 19244-3412, and 19247-4381.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on April 26, 2002, and
by letter on May 17, 2002. Firm initiated recall is complete.
REASON
Blood products, whose freeze time exceeded the firm's specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0352-5.
CODE
Unit number 19250-3253.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on May 9, 2002, and
by letter on May 21, 2002. Firm initiated recall is complete.
REASON
Blood product, whose freeze time exceeded the firm's specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0357-5.
CODE
Unit number 7796973.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on September 30, 2004. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but there was insufficient documentation to confirm that the product was actually leukoreduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0385-5.
CODE
Unit 192514107.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on May 22, 2002. Firm
initiated recall is complete.
REASON
Blood product, which may have been stored at unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0387-5.
CODE
Units F98309, F98310, and F98311.
RECALLING FIRM/MANUFACTURER
By telephone on September 24, 2004. Firm initiated recall is complete.
REASON
Blood products, which were labeled incorrectly as having had additive solution added, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) Hospitak, REF-903-GM, IPPB Circuit Exhalation
Valve & Nebulizer Circuit Universal 4î Length
with Adapter. Recall # Z-0279-05;
b) Hospitak, REF-903-E, IPPB Ventilator Circuit.
Recall # Z-0280-05;
c) Hospitak, REF-1011, IPPB Ventilator Circuit.
Recall # Z-0281-05;
d) Hospitak, REF CD1N4Y-E, Mapleson D. Anesthesia
Non-Rebreathing Circuit, 10î. Recall # Z-0282-05;
e) Hospitak, REF CJ4N2Y-E, Jackson-Rees, Anesthesia
Non-Rebreathing Circuit, 12î. Recall # Z-0283-05;
f) Hospitak, REF CJ4N1VY-E, Jackson-Rees, Anesthesia
Non-Rebreathing Circuit, 12î. Recall # Z-0284-05;
g) Hospitak, REF 962-E, Adapter 22mm/15mm.
Recall # Z-0285-05;
h) Hospitak, REF 1450, Face Ten Mask w/Aerosol
Tubing 60î, Oxygen Tubing 7î and Connector.
Recall # Z-0286-5;
i) Hospitak, REF 8026, Adapter 22mm/15mm.
Recall # Z-0275-5;
j) Viasys, REF BLD-14772, Pulmanex Adult
Transport Ventilator Circuit with Exhalation
Valve, Non-Heated, 72î. Recall # Z-0287-05;
k) Viasys, REF BLD-14660, Pulmanex Adult
Transport Circuit w/Exhalation Valve,
Non-Heated, 60î. Recall # Z-0288-05;
l) Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D.
x 22mm O.D. x 15mm I.D. Recall # Z-0289-05;
m) Viasys, REF BLD-8101, Pulmanex Carhill Valve Kit:
Medium Adult. Recall # Z-0290-05;
n) Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit:
Large Adult. Recall # Z-0291-05;
o) Unomedical REF 962MM, Adapter 22mm/15mm.
Recall #Z-0292-05;
p) Drager Medical, REF 40314160, Bird-Bennet-Monaghan
IPPB circuit, Latex Free. Recall # Z-0293-05.
CODE
a) Lot numbers 04-35 and 04-36;
b) Lot number 04-35;
c) Lot numbers 04-40 and 04-41;
d) Lot number 04-38;
e) Lot number 04-37;
f) Lot number 04-37;
g) Lot numbers 04-37, 04-38, 04-40, 04-41,
04-44, 04-45, 04-46, 04-47, and 04-48;
h) Lot numbers 04-42, 04-43, and 04-47;
i) Lot numbers 04-36, 04-37, and 04-47;
j) Lot numbers 23604005 and 31504003;
k) Lot number 31304004;
l) Lot numbers 27904001 and 29504001;
m) Lot numbers 28004002 and 29604001;
n) Lot number 29404003;
o) Lot numbers 04-35, 04-36, 04-37,
and 04-40.
p) Lot numbers 04-38 and 04-44.
RECALLING FIRM/MANUFACTURER
Unomedical, Inc., McAllen, TX, by Public Safety Alert on November 30, 2004, and letters and press release on December 2, 2004. Firm initiated recall is ongoing.
REASON
Adapters have been found to be blocked or occluded ‚ potentially preventing exhalation or inhalation.
VOLUME OF PRODUCT IN COMMERCE
400,487 total adapters.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Pulmonetic System Universal Cable Adaptor for
use on LTV Series Ventilator, Model 800.
Recall # Z-0274-05;
b) Pulmonetic System Universal Cable Adaptor for
use on LTV Series Ventilator, Model 950.
Recall # Z-0294-05;
c) Pulmonetic System Universal Cable Adaptor for
use on LTV Series Ventilator, Model 900.
Recall # Z-0295-05;
d) Pulmonetic System Universal Cable Adaptor for
use on LTV Series Ventilator, Model 1000.
Recall # Z-0296-05.
CODE
All Universal Cable Adapters identified on outer packaging as part no. 17820-001 and distributed between 11/02/04 and 11/08/04.
RECALLING FIRM/MANUFACTURER
Pulmonetic Systems, Inc., Minneapolis, MN, by telephone beginning on November 19, 2004. Firm initiated recall is ongoing.
REASON
The Universal Cable Adaptor, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.
VOLUME OF PRODUCT IN COMMERCE
1,129 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1 1û2î
Needle Catalog Number: 4250. Recall # Z-0222-05;
b) Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1î
Needle Catalog Number: 4251. Recall # Z-0223-05;
c) Portex Hypodermic Needle-Pro 5 ml Syringe,
21g x 1 1û2î Needle Catalog Number: 4252.
Recall # Z-0224-05;
d) Hypodermic Needle-Pro 5 ml Syringe, 21g x 1î
Needle Catatlog Number: 4253. Recall # Z-0225-05;
e) Portex Hypodermic Needle-Pro 5 ml Syringe, 22g x 1 1û2î
Needle Catalog Number: 4254. Recall # Z-0226-05;
f) Portex Pro-Vent Arterial Blood Sampling Kit with
Dry Lithium Heparin for Gases and Electrolytes
Catalog Number: 4589P-1. Recall # Z-0227-05;
g) Portex Tracheostomy Tube Decannulation Cap for
use only with Fenestrated Tracheostomy Tubes
Catalog Number: 519000, Recall # Z-0228-05;
h) Portex Tracheostomy Tube Decannulation Cap
for use only with Fenestrated Tracheostomy Tubes
Catalog Number: 519000, Recall # Z-0228-05;
i) Portex Lo-Profile Tracheostomy Tube Decannulation
Cap Catalog Number: 582000, Recall # Z-0229-05;
j) Portex Dual-Axis Swivel Adapter Catalog Number:
525151, Recall # Z-0230-05;
k) Portex PEEP-KEEP Dual-Axis SwivelAdapter
Catalog Number: 525351. Recall # Z-0231-05;
l) Portex Single Swivel Adapter Catalog Number: 525451.
Recall # Z-0232-05;
m) Fiberoptic Bronchoscope Dual-Axis Swivel
Adapter Catalog Number: 625191.
Recall # Z-0233-05;
n) Portex 3 Way Stopcock Catalog Number: T1102.
Recall # Z-0234-05;
o) Portex 3 Way Stopcock Catalog Number: T1103.
Recall # Z-0235-05;
p) Portex 3 Way Stopcock Catalog Number: T1202.
Recall # Z-0236-05;
q) Portex 3 Way Stopcock Catalog Number: T1203.
Recall # Z-037-05;
r) Portex 4 Way ìT-Handleî Stopcock Catalog
Number: T1204. Recall # Z-0238-05;
s) Portex 4-Way Stopcock Catalog Number: T1206.
Recall # Z-0239-05;
t) Portex ULTRA-FLO 4 - Way Stopcock Catalog
Number: T1209.Recall # Z-0240-05;
u) Portex ULTRA-FLO 4 ‚ Way Stopcock Catalog
Number: T1210. Recall # Z-241-05;
v) Portex High Pressure 1-Way Stopcock Catalog
Number: T8200. Recall # Z-0242-05;
w) Portex High Pressure 4 - Way Stopcock Catalog
Number: T8202. Recall # Z-0243-05;
x) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1481. Recall # Z-0244-05;
y) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1483. Recall # Z-0245-05;
z) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1488. Recall # Z-0246-05;
aa) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1515.Recall # Z-0247-05;
bb) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1540. Recall # Z-0248-05;
cc) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1554. Recall # Z-0249-05;
dd) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1560. Recall # Z-0250-05;
ee) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1562. Recall # Z-0251-05;
ff) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1576. Recall # Z-0252-05;
gg) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1615. Recall # Z-0253-05;
hh) Portex Custom Pro-Vent Arterial Blood Sampling
Kit Catalog Number: G1696. Recall # Z-0254-05;
ii) Portex 1-Way Stopcock Catalog Number: T1201.
Recall # Z-0255-05.
CODE
a) Lot numbers starting with: 1, K1, K51, K52, K53;
b) Lot numbers starting with: 1, K1, K2, K50, K51,
K52, K53;
c) Lot numbers starting with: K1, K2, K50, K51,
K52, K53 and 111381,111448, 111449;
d) Lot numbers starting with: K1, K53;
e) Lot numbers starting with: 1, K1, K2, K50, K51,
K52, K53;
f) Lot numbers starting with: 1, K1, K2, K50, K51,
K52, K53, K541, K542, K543;
h) Lot numbers starting with: 0, 1, 911, 912, K1,
K2, K50, K51, K52;
i) Lot numbers starting with: 1, K1, K2, K50;
j) Lot numbers starting with: 0, 1, 910, 912, K1,
K2, K50, K51, K52;
k) Lot numbers starting with: 0, 1, 912, K1, K2,
K50, K52;
l) Lot numbers starting with: 0, 1, K1, K2, K50,
K51;
m) Lot numbers starting with: 0, 1, 911, 912, K1,
K2, K50, K51, K52;
n) Lot numbers starting with: 0, 909, 911, K1,
K51, K52;
o) Lot numbers starting with: 1, K1;
p) Lot numbers starting with: 1, K1;
q) Lot numbers starting with: 0, 1, 911, 912, K1,
K2, K50, K51, K52;
r) Lot numbers starting with: 0, 1, 909, 911, 912,
K1;
s) Lot numbers starting with: 0, 1, 911, 912, K1,
K50, K52;
t) Lot numbers starting with: 0, 1, K1, K2, K51;
u) Lot numbers starting with: 0, 1, 909, 911, K1,
K50, K51;
v) Lot numbers starting with: 0;
w) Lot numbers starting with: 0, 1, K1, K2, K51,
K52;
x) Lot numbers starting with: 1, K1, K2, K50, K51;
y) Lot numbers starting with: 1, K1, K52;
z) Lot numbers starting with: 1, K1, K2, K51, K53;
aa) Lot numbers starting with: 1, K1, K2, K540;
bb) Lot number 110727;
cc) Lot numbers starting with: 1, K1, K2, K50, K51,
K52, K53;
dd) Lot numbers starting with: 1, K1, K2, K50,
K51, K52, K53;
ee) Lot numbers starting with: 1, K1, K50, K51,
K541;
ff) Lot numbers starting with: K1, K2, K51;
gg) Lot numbers starting with: 1, K1, K2, K51;
hh) Lot number: K513947;
ii) Lot Numbers starting with: 0,K1, K2.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH, by letters dated September 9, and September 17, 2004. Firm initiated recall is ongoing.
REASON
Sterility of the device is compromised due to packaging defects.
VOLUME OF PRODUCT IN COMMERCE
909,546 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Magnetic Resonance Imaging Systems under the following names: Visart, Excelart, Excelart P2, Excelart P3, Excelart SPIN, Excelart VANTAGE. Recall # Z-0270-05.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc., Tustin, CA, by letter on October 6, 2004. Firm initiated recall is ongoing.
REASON
Software defect causes images to be rotated 180 degrees.
VOLUME OF PRODUCT IN COMMERCE
67 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Linear Array Transducer Type: 8809. Recall # Z-0271-05.
CODE
Serial Numbers: 1831984, 1831985, 1831986, 1831987, 1831989, 1831990, 1831992, 1832004, 1832007, 1844219, 1844235, 1844239, 1844240, 1844241, 1847871, 1847875, 1847889.
RECALLING FIRM/MANUFACTURER
B & K Medical Systems Inc., North Billerica, MA, by letter dated November 12, 2004. Firm initiated recall is ongoing.
REASON
Defect at probe tip may affect sterilization and electrical safety.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Magnetic Resonance Imaging Systems, under the following names: Visart Excelart P2 Excelart P3 Excelart SPIN. Recall # Z-0273-05.
CODE
No specific codes were listed.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc, Tustin, CA, by letter on August224, 2004. Firm initiated recall is ongoing.
REASON
Software defect causes patient identification number to be truncated.
VOLUME OF PRODUCT IN COMMERCE
39
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Baxter System 1000 Single Patient Hemodialysis Delivery System, Model SYS1000; all series 1000 instruments labeled as System 1000. AltraTouch 1000, Baxter Tina and Baxter Aurora; Recall # Z-0274-05.
CODE
All system 1000 units with serial numbers prior to 22224.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Deerfield, IL, by letters on May 28, 2003. Firm initiated recall is ongoing.
REASON
The air detector may not detect air bubbles consistently at the selected limit.
VOLUME OF PRODUCT IN COMMERCE
28,482 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) OTC Pregnancy Tests. Name: Sure Check hCG
Midstream Pregnancy Test --- Description:
the Sure Check hCG Midstream Pregnancy test
consists of a lateral flow membrane pad
containing anti-’ hCG monoclonal antibody
conjugated to colloidal gold contained in a
plastic ìwandî with an absorbent wick at
one end. Catalog numbers are solely used for
ordering by the different distributors.
This OTC product is shipped as either bulk
packaged product or as private labeled
material labeled as follows:
SURE CHECKô ONE STEP Pregnancy Test ---
1 TEST; UPC 6 07158 00110 3; Catalog
# PT110SURE/12.
SURE CHECKô ONE STEP Pregnancy Test ---
2 TESTS; UPC 6 07158 00112 7; Catalog #
PT112/24.
exactô pregnancy test. UPC 0 60383 66207 3;
Catalog # PT110-N4 (Neuco).
exactô pregnancy test --- 2 tests;
UPC 0 60383 68179; Catalog # PT112-N4 (Neuco).
OUR BEST NOTRE MEILLEUR ONE STEP PREGNANCY
TEST (TEST DE GROSSESSE EN UNE ETAPE) ---
1 TEST --- UPC 0 61925 57608; Catalog #
PT110-N7 (Neuco).
BODY BASICSô Pregnancy Test (Test de grossesse)
--- 1 Test --- UPC 0 57627 71110 9;
Catalog # PT110-N6/12 (Neuco)
Option+ TEST DE GROSSESSE UNE ETAPE/ONE
STEP PREGNANCY TEST - UPC 7 71290 05402 7;
Catalog # PT110-N2 (Neuco).
True-Testô Pregnancy Test Kit
(Examen del Embarazo) One Step Testing
1 Test - UPC 0 61406 37505 5;
Catalog # PT110-R1 (Ultras).
Shaw's ONE-STEP Pregnancy Test -1 TEST
Made in USA; UPC 0 45674 65589 7;
Catalog # PT110-S1.
Harris Teeter Pregnancy Test Kits One Step ‚
Easy to use Pregnancy Test Kit ---
Two Home Test Kits -UPC 0 72036 72061 0;
Catalog # PT112-R2 (Harris Teeter).
Bulk packaged product is assigned
Catalog # PT110, with varying quantities
510(k) K961965.
Recall # Z-0276-05;
b) OTC Pregnancy Tests. Name: Sure Check hCG
Cassette Pregnancy Test. --- Description:
the Sure Check hCG Cassette Pregnancy test
consists of a lateral flow membrane pad
containing anti-’ hCG monoclonal antibody
conjugated to colloidal gold contained in
a plastic cassette. It differs from the
Sure Check Midstream product in that the
lateral flow membrane pad is placed in a
cassette and the urine sample is added by
pipette rather than by urinating on the
absorbent wick. The device is packaged in
a foil pouch with desiccant. This product
is shipped as bulk packaged product of
varying quantities (Catalog # PT127-OTC;
Catalog # PT210 ordered by LABSCO).
510(k) K933529/A. Recall # Z-0277-05.
CODE
a) Lot U030504 (Exp. 30 AUG 06).
Recall Expansion: lots U032904 (Exp. 31 AUG 06),
U060804 (Exp. 30 NOV 06),
U040104 (Exp. 30 SEP 06),
U040904/1 (Exp. 30 SEP 06);
b) Lot U040904 (Exp. 30 SEP),
Recall Expansion: lot U032904/1 (Exp. 30 AUG 06).
RECALLING FIRM/MANUFACTURER
Chembio Diagnostic System Inc., Medford, NY, by letters on October 6, 2004, October20, 2004 and November 9, 2004. Firm initiated recall is ongoing.
REASON
Poor sealing of pouches and degradation of products. Investigation revealed invalid results (no control lines) and some false negatives.
VOLUME OF PRODUCT IN COMMERCE
359,610 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Medtronic Midas Rex Legend High Speed Pneumatic System. Recall # Z-0278-05.
CODE
Serial Numbers: A0046-V02 ; A0079-V01 ; A0089-V01 ; A0091-V01 ; A0096-V02 ; A0106-V02 ; A0233-V02 ; A0235-V02 ; A0249-V01 ; A0251-V01 ; A0259-V01 ; A0260-V02 ; A0261-V02 ; A0264-V01 ; A0271-V02 ; A0272-V02 ; A0274-V02 ; A0275-V02 ; A0281-V02 ; A0406-V02 ; A0422-V01 ; A0424-V01 ; A0426-V01 ; A0444-V01 ; A0448-V01 ; A0453-V02 ; A0454-V02 ; A0456-V02 ; A0535-V02 ; A0693-V01 ; A0697-V01 ; A0698-V01 ; A0699-V01 ; A0710-V02 ; A0717-V02 ; A0725-V02 ; A0726-V02 ; A0735-V02 ; A0736-V02 ; A0744-V02 ; A0750-V02 ; A0761-V02 ; A0837-V01 ; A0838-V01 ; A0854-V01 ; A0855-V01 ; A0863-V02 ; A1008-V02 ; A1079-V02 ; A1081-V02 ; A1082-V02 ; A1083-V02 ; A1084-V02 ; A1114-V02 ; A1136-V01 ; A1137-V01 ; A1138-V01 ; A1145-V01 ; A1147-V01 ; A1148-V01 ; A1300-V02 ; A1304-V02 ; A1341-V02 ; A1342-V02 ; A1391-V02 ; A1393-V02 ; A1467-V02 ; A1475-V01 ; A1499-V02 ; A1533-V02 ; A1535-V02 ; A1545-V02 ; A1659-V02 ; A1660-V02 ; A2031-V01 ; A2169-V01 ; A2309-V02 ; A2310-V02 ; A2312-V02 ; A2314-V02 ; A2316-V02 ; A2318-V02 ; A2321-V02 ; A2322-V02 ; A2325-V02 ; A2342-V01 ; A2344-V01 ; A2346-V01 ; A2356-V01 ; A2363-V01 ; a2366-v01 ; A3195-V02 ; A3368-V02 ; A3374-V01 ; A3671-V02 ; A3683-V02 ; A3692-V01 ; A3927-V02 ; A3985-V02 ; A3996-V01 ; A4244-V01 ; A4300-V02 ; A4340-V01 ; A4635-V02 ; A4700-V02 ; A4712-V02 ; A4718-V02 ; A4721-V02 ; A4722-V02 ; A4725-V02 ; A4731-V02 ; A5263-V01 ; A5270-V01 ; A5271-V01 ; A5368-V01 ; A5375-V01 ; A5539-V01 ; A5540-V01 ; A5541-V01 ; A5547-V01 ; A5553-V01 ; A5558-V01 ; A5563-V02 ; A5900-V01 ; A5902-V01 ; A5903-V01 ; A5904-V01 ; A5906-V01 ; A5908-V01 ; A5909-V01 ; A5910-V01 ; A5912-V01 ; A5913-V01 ; A5914-V01 ; A5920-V02 ; A5923-V02 ; A5923-VO2 ; A5924-V02 ; A5925-V02 ; A5926-V02 ; A5927-V02 ; A5928-V02 ; A5929-V02 ; A5935-V02 ; A5936-V02 ; A5939-V02 ; A5940-V02 ; A5941-V02 ; A5943-V02 ; A5944-V02 ; A5945-V02 ; A5948-V02 ; A5949-V02 ; A5952-V02 ; A5955-V02 ; A5956-V02 ; A5957-V02 ; A5959-V02 ; A6034-V02 ; A6035-V02 ; A6036-V02 ; A6037-V02 ; A6038-V02 ; A6039-V02 ; A6040-V02 ; A6041-V02 ; A6042-V02 ; A6043-V02 ; A6044-V02 ; A6048-V02 ; A6049-V02 ; A6050-V02 ; A6051-V02 ; A6052-V02 ; A6054-V01 ; A6055-V01 ; A6056-V01 ; A6057-V01 ; A6058-V01 ; A6059-V01 ; A6060-V01 ; A6061-V01 ; A6062-V01 ; A6066-V01 ; A6067-V01 ; A6068-V01 ; A6069-V01 ; A6070-V01 ; A6071-V01 ; A6072-V01 ; A6073-V02 ; A6075-V02 ; A6077-V02 ; A6078-V02 ; A6079-V02 ; A6080-V02 ; A6082-V02 ; A6235-V02 ; A6236-V02 ; A6237-V02 ; A6239-V02 ; A6240-V02 ; A6241-V02 ; A6242-V02 ; A6243-V02 ; A6245-V02 ; A6247-V02 ; A6248-V02 ; A6250-V02 ; A6251-V02 ; A6252-V02 ; A6253-V02 ; A6256-V01 ; A6257-V01 ; A6258-V01 ; A6259-V01 ; A6260-V01 ; A6262-V01 ; A6264-V01 ; A6266-V01 ; A6267-V01 ; A6269-V01 ; A6271-V01 ; A6272-V01 ; A6273-V01 ; A6435-V02 ; A6436-V02 ; A6441-V01 ; A6442-V01 ; A6443-V01 ; A6444-V01 ; A6448-V01 ; A6450-V01 ; A6453-V01 ; A6455-V01 ; A6459-V01 ; A6475-V02 ; A6476-V02 ; A6477-V02 ; A6479-V02 ; A6480-V02 ; A6481-V02 ; A6483-V02 ; A6484-V02 ; A6486-V02 ; A6487-V02 ; A6488-V02 ; A6489-V02 ; A6490-V02 ; A6491-V02 ; A6492-V02 ; A6493-V02 ; A6494-V02 ; A6497-V02 ; A6498-V02 ; A6499-V02 ; A6500-V02 ; A6502-V02 ; A6509-V02 ; A6515-V02 ; A6516-V02 ; A6517-V02 ; A6518-V02 ; A6726-V01 ; A6729-V01 ; A6736-V01 ; A6741-V01 ; A6742-V01 ; A6743-V01 ; A6744-V01 ; A6745-V01 ; A6746-V01 ; A6747-V01 ; A6748-V01 ; A6749-V01 ; A6750-V01 ; A6751-V01 ; A6752-V01 ; A6753-V01 ; A6754-V01 ; A6880-V01 ; A6882-V01 ; A6883-V01 ; A6884-V01 ; A6886-V01 ; A6888-V01 ; A6892-V01 ; A6893-V01 ; A6894-V01 ; A6895-V01 ; A6896-V01 ; A7074-V01 ; A7075-V01 ; A7076-V01 ; A7077-V01 ; A7078-V01 ; A7079-V01 ; A7080-V01 ; A7081-V01 ; A7082-V01 ; A7083-V01 ; A7113-V02 ; A7114-V02 ; A7115-V02 ; A7117-V02 ; A7118-V02 ; A7119-V02 ; A7120-V02 ; A7121-V02 ; A7122-V02 ; A7123-V02 ; A7124-V02 ; A7127-V02 ; A7128-V02 ; A7129-V02 ; A7130-V02 ; A7131-V02 ; A7132-V02 ; A7134-V02 ; A7136-V02 ; A7142-V02 ; A7384-V01 ; A7385-V01 ; A7386-V01 ; A7388-V01 ; A7389-V01 ; A7390-V01 ; A7391-V01 ; A7392-V01 ; A7393-V01 ; A7394-V01 ; A7395-V01 ; A7397-V01 ; A7398-V01 ; A7399-V01 ; A7401-V01 ; A7402-V01 ; A7403-V01 ; A7404-V01 ; A7405-V01 ; A7407-V01 ; A7411-V01 ; A7415-V01 ; A7416-V01 ; A7417-V01 ; A7418-V01 ; A7419-V01 ; A7421-V01 ; A7422-V01 ; A7423-V01 ; A7424-V01 ; A7425-V01 ; A7427-V01 ; A7436-V02 ; A7440-V02 ; A7441-V02 ; A7444-V02 ; A7445-V02 ; A7446-V02 ; A7447-V02 ; A7448-V02 ; A7449-V02 ; A7453-V02 ; A7454-V02 ; A7455-V02 ; A7462-V02 ; A7469-V02 ; A7470-V02 ; A7471-V02 ; A7474-V02 ; A7475-V02 ; A7476-V02 ; A7477-V02 ; A7478-V02 ; A7479-V02 ; A7480-V02 ; A7481-V02 ; A7482-V02 ; A7483-V02 ; A7871-V01 ; A7961-V02 ; A7962-V02 ; A7963-V02 ; A7964-V02 ; A7965-V02 ; A7966-V02 ; A7967-V02 ; A7968-V02 ; A7969-V02 ; A7970-V02 ; A7981-V02 ; A7982-V02 ; A7983-V02 ; A7984-V02 ; A7985-V02 ; A7986-V02 ; A7987-V02 ; A7988-V02 ; A7989-V02 ; A7990-V02 ; B0019-V02 ; B0020-V02 ; B0027-V02 ; B0032-V02 ; B0033-V02 ; B0034-V02 ; B0037-V02 ; B0038-V02 ; B0044-V02 ; B0046-V02 ; B0047-V02 ; B0048-V02 ; B0051-V02 ; B0058-V02 ; B0060-V02 ; B0064-V02 ; B0066-V02 ; B0071-V02 ; B0072-V02 ; B0074-V02 ; B0079-V02 ; B0092-V02 ; B0102-V02 ; B0108-V02 ; B0111-V02 ; B0114-V02 ; B0121-V02 ; B0122-V02 ; B0133-V02 ; B0137-V02 ; B0166-V02 ; B0179-V02 ; B0225-V02 ; B0248-V01 ; B0283-V01 ; B0297-V02 ; B0298-V02 ; B0300-V02 ; B0301-V02 ; B0302-V02 ; B0303-V02 ; B0305-V02 ; B0306-V02 ; B0308-V02 ; B0315-V02 ; B0316-V02 ; B0319 ; B0320-V02 ; B0321-V02 ; B0325-V02 ; R8002-V01 ; T0088-V01 ; T0236-V02 ; T0400 ; T0447-V02 ; T0458 ; T0461-V02 ; T0465-V01 ; T0486 ; T0490-V02 ; T0500-V02 ; T0505-V02 ; T0514-V02 ; T0615-V01 ; T0619-V01 ; T0620 ; T0681-V02 ; T0687-V02 ; T0688-V02 ; T0699-V02 ; t0706 ; T073 ; T0753 ; T0756-V01 ; T0972-V02 ; T0995-V01 ; T1012-V02 ; T1020-V02 ; T1021-V02 ; T1133-V02 ; T1137 ; T1159-V01 ; T1257-V02 ; T1259-V02 ; T1299-V02 ; T1315-V01 ; T1318 V)1 ; T1322-V01 ; T1332-V01 ; T1337-V01 ; T1364-V02 ; T1368-V02 ; T1372-V01 ; T1375-V02 ; T1381-V02 ; T1391-V02 ; T1392-V02 ; T1414-V01 ; T1433-V01 ; T1434-V01 ; T1435-V01 ; T1462-V02 ; T1525-V02 ; T1541-V01 ; T1548-V01 ; T1549-V01 ; T1550-V01 ; T1559-V01 ; T1573-V02 ; T1579-V02 ; T1580 ; T1603-V02 ; T1604-VO2 ; T1606-V02 ; T1625-V02 ; T1636-V01 ; T1639-V01 ; T1642 ; T1651 ; T1654 ; T1669-V01 ; t1696-v02 ; T1697 ; T1699 ; T1702-V02 ; T1705-V02 ; T1715-V02 ; T1717-V02 ; T1719-V02 ; T1727-V02 ; T1729-V02 ; T1737-V02 ; T1738-V02 ; T1755 ; T1760-V02 ; T1766-V02 ; T1772-V02 ; T1818-V01 ; T1827-V01 ; T1832 ; T1835-V01 ; T1918-V02 ; T1924-V02 ; T1947-V02 ; T1955-V02 ; T1957-V02 ; T1961-V02 ; T1963-V02 ; T1965-V02 ; T1966-V02 ; T1969-V02 ; T1971-V02 ; T1973-V02 ; T1975-V02 ; T1979-V02 ; T1999-V01 ; T2004-V01 ; T2016-V01 ; T2019-V01 ; T2027-V01 ; T2031-V01 ; T2056-V02 ; T2057-V02 ; T2060-V02 ; T2063-V02 ; T2069-V01 ; T2070-V02 ; T2071-V01 ; T2077-V01 ; T2079-V01 ; T2083-V01 ; T2087-V01 ; T2090-V01 ; T2095-V01 ; T2100-V01 ; T2164-V02 ; T2166-V02 ; T2167-V02 ; T2168-V02 ; T2170-V02 ; T2175-V02 ; T2181-V02 ; T2182-V02 ; T2183-V02 ; T2185-V02 ; T2187-V02 ; T2205-V02 ; T2208-V02 ; T2211-V02 ; T2276-V02 ; T2301-V02 ; T2343-V02 ; T2362-V01 ; T2368-V01 ; T2385-V01 ; T2395-V01 ; T2401-V01 ; T2408 ; T2415-V02 ; T2418-V02 ; T2421-V02 ; T2424-V02 ; T2431-V02 ; T2437-V02 ; T2447-V02 ; T2457-V02 ; T2461-V02 ; T2464-V02 ; T2476-V01 ; T2480-V01 ; T2484-V01 ; t2485-v01 ; T2487-V01 ; T2522-V01 ; T2523-V01 ; T2528-V01 ; T2529 ; T2530 ; T2533-V01 ; T2534-V01 ; T2540-V01 ; T2541-V01 ; T2545-V01 ; T2674-V02 ; T2675-V02 ; T2678-V02 ; T2686-V02 ; T2690-V02 ; T2698-V02 ; T2703-V02 ; T2710-V02 ; T2723-V02 ; T2726-V02 ; T2774-V02 ; T2794-V02 ; T2830-V02 ; T2833-V02 ; T2885-V02 ; T2887-V02 ; T2889-V02 ; T2892-V02 ; T2920-V01 ; T2939-V01 ; T2940 ; T2941-V01 ; T2947-V01 ; T2960-V01 ; T2963 ; T2968-V01 ; T2969-V02 ; T2970-V01 ; T2971-V01 ; T2972-V01 ; T2977-V01 ; T2983-V01 ; T2984-V01 ; T3017-V02 ; T3028-V02 ; T3033-V02 ; T3036-V02 ; T3042-V02 ; T3047-V02 ; T3050-V02 ; T3051-V02 ; T3058-V02 ; T3059-V02 ; T3061-V02 ; T3068-V02 ; T3073-V02 ; T3075-V02 ; T3076-V02 ; T3081-V02 ; T3086-V02 ; T3089-V02 ; T3310-V01 ; T3324-V01 ; T3328-V01 ; T3352-V02 ; T3357-V02 ; T3360-V02 ; T3363-V02 ; T3366-V02 ; T3376-V02 ; T3384-V02 ; T3387-0-V02 ; T3388-V02 ; T3391-V02 ; T3393-V02 ; T3394-V02 ; T3400-V02 ; T3601-V01 ; T3606-V01 ; T3617-V01 ; T3619-V01 ; T3630-V02 ; T3635-V02 ; T3639-V02 ; T3645-V02 ; T3651-V02 ; T3655-V02 ; T3659-V02 ; T3662-V02 ; T3794-V02 ; T3799-V02 ; T3801-V02 ; T3808-V02 ; T3809-V02 ; T3821-V02 ; T3829-V02 ; T3831-V02 ; T4003 ; T4007-V01 ; T4015-V01 ; T4016-V01 ; T4019-V01 ; T4021-V01 ; T4050-V02 ; t4053-v02 ; T4058-V02 ; T4062-V02 ; T4070-V02 ; T4078-V02 ; T4133-V02 ; T4134-V02 ; T4139-V02 ; T4141-V01 ; T4143-V02 ; T4147-V02 ; T4148-V02 ; T4150-V02 ; T4152-V02 ; T4155-V02 ; t4161 ; T4163-V02 ; T4165-V02 ; T4169-V02 ; T4173-V02 ; T4190-V02 ; T4359-V01 ; T4361-V01 ; T4369-V01 ; T4370 ; T4385-V01 ; T4388-V01 ; T4395-V01 ; T4396-V01 ; T4397-V01 ; T4460-V02 ; T4464-V02 ; T4469-V02 ; T4476-V02 ; T4479-V01 ; t4513 ; T4530-V02 ; T4538 ; T4543-VO2 ; T4547-V02 ; T4551-V02 ; T4552-V02 ; T4554-V02 ; T4561-V02 ; T4567-V02 ; T4575-V02 ; T4599-V02 ; T4604-V02 ; T4607-V02 ; T4609-V02 ; T4681-V01 ; T4683-V01 ; T4692-V01 ; T4693-V01 ; T4694-V01 ; T4697-V01 ; T4700-V01 ; T4704-V01 ; T4773-V01 ; T4776-V01 ; T4778-V01 ; T4779-V01 ; T4782-V01 ; T4793-V01 ; T4794-V01 ; T4802-V01 ; T4805-V01 ; T5220 ; T5224 ; T5227-V02 ; T5228-V02 ; T5241-V02 ; T5244-V02 ; T5253-V02 ; T5261-V02 ; T5276-V02 ; T5277-V02 ; T5283-V02 ; T5287-V02 ; T5289-V02 ; T5290-V02 ; T5293-V02 ; T5295-V02 ; T5300-V02 ; T5302-V02 ; T5303-V02 ; T5317-V02 ; T5324-V02 ; T5327-V02 ; T5330-V02 ; T5332-V02 ; T5334-V02 ; T5335-V02 ; T5337-V02 ; T5350-V02 ; T5359 ; T5376-V02 ; T5378-V02 ; T5380-V02 ; T5384-V02 ; T5389-V02 ; T5396-V01 ; T5397-V01 ; T5398-V01 ; T5400-V01 ; T5401-V01 ; T5402-V01 ; T5406-V01 ; T5427-V01 ; T5433-V01 ; T5440-V01 ; T5441-V01 ; T5443-V01 ; T5445-V01 ; T5447-V01 ; T5448-V01 ; T5453-V01 ; T5547-V02 ; T5556-V02 ; T5558-V02 ; T5564VO2 ; T5704-V02 ; T5709-V02 ; T5710-V02 ; T5711-V02 ; T5713-V02 ; T5714-V02 ; T57152-V02 ; T5718-V02 ; T5729-V02 ; T5730-V02 ; T5733-V02 ; T5737-V02 ; T5747-V02 ; T5749-V02 ; T5750-V02 ; T5752-V02 ; T5753-V02 ; T5756-V02 ; T5757-V02 ; T6007-V01 ; T600-V02 ; T6020-V01 ; T6026 ; T6027-V01 ; T6046-V02 ; T6050-V02 ; T6067-V02 ; T6077-V02 ; T6079-V02 ; T6081-V02 ; T6145-V01 ; T6159-V01 ; T6188-V02 ; T6193-V02 ; T6196-V02 ; T6198-V02 ; T6205-V02 ; T6211-V02 ; T6215-V02 ; T6216-V02 ; T6226-V02 ; T6235 ; T6241-V02 ; T6286-V01 ; T6292-V01 ; T6293-V01 ; T6302-V01 ; T6303-V01 ; T6307-V02 ; T6309-V02 ; T6315-V02 ; T6318-V02 ; T6321-V02 ; T6322-V02 ; T6325-V02 ; T6326-V02 ; T6327-V02 ; T6354-V02 ; T6420-V01 ; T6426-V01 ; T6439-V01 ; T6442-V01 ; T6447-V02 ; T6451-V02 ; T6455-V02 ; T6468-V02 ; T6473-V02 ; T6474-V02 ; T6488-V02 ; T6490-V02 ; T6496-V02 ; T6507-V02 ; T6508-V02 ; T6513-V02 ; T6667-V02 ; T6668-V02 ; T6669-V02 ; T6672-V02 ; T6676-V02 ; T6684-V02 ; T6685-V02 ; T6701-V02 ; T6704-V02 ; T6706-V02 ; T6770-V01 ; T6771-V01 ; T6799-V01 ; T6816-V02 ; T6827-V01 ; T6830-V01 ; T6833-V01 ; T6836-V01 ; T6843-V01 ; T6844-V01 ; T6881-V01 ; T6882-V01 ; T6884-V01 ; T6886 ; T6886-V01 ; T6892-V01 ; T6893-V01 ; T6906-V01 ; T6911-V01 ; T6921-V01 ; T6925-V01 ; T6927-V01 ; T6928-V01 ; T6933-V02 ; T6939-V02 ; T6941-V02 ; T6943-V02 ; T6947-V02 ; T6958-V02 ; T7001-V02 ; T7017-V02 ; T7021-V01 ; T7024 ; T7031-V01 ; T7032-V01 ; T7038-V01 ; T7058-V01 ; T7062-V01 ; T7063-V01 ; T7064-V01 ; T7074-V01 ; T7082-V02 ; T7085-V02 ; T7086-V02 ; T7088-V02 ; T7094-V02 ; T7168-V01 ; T7170-V01 ; T7172-V01 ; T7174-V01 ; T7256-V02 ; T7257-V02 ; T7262-V02 ; T7268-V02 ; T7275-V02 ; T7288-V02 ; T7289-V02 ; T7291-V02 ; T7292-V02 ; T7293-V02 ; T7298-V02 ; T7305-V02 ; T7312-V02 ; T7314-V02 ; T7316-V02 ; T7328-V01 ; T7335-V01 ; T7338-V01 ; T7340-V01 ; T7347-V01 ; T7513-V02 ; T7514-V02 ; T7518-V02 ; T7520-V02 ; T7523-V02 ; T7525-V02 ; T7682-V02 ; T7754-V01 ; T7757-V01 ; T7758-V01 ; T7762-V01 ; T7766-V01 ; T7767-V01 ; T7780-V02 ; T7785-V02 ; T7787-V02 ; T7790-V02 ; T7793-V02 ; T7795-V02 ; T7801-V02 ; T7819-V01 ; T7823-V01 ; T7827-V01 ; T7836-V02 ; T7842 ; T7888-V02 ; T7890-V02 ; T7903-V02 ; T7927-V01 ; T7933-V01 ; T7937-V01 ; T7938-V01 ; T7940-V01 ; T7942-V01 ; T7944-V01 ; T7988-V01 ; T7989-V01 ; T7991-V01 ; T7999-V01 ; T8019-V02 ; T8023-V02 ; T8024-V02 ; T8030-V01 ; T8045-V01 ; T8098-V01 ; T8110-V01 ; T8114-V01 ; T8116-V01 ; T8123-V02 ; T8133-V02 ; T8141-V02 ; T8143-V02 ; T8147-V02 ; T8151-V02 ; t8154-V02 ; T8155-V02 ; T8159-V02 ; T8160-V01 ; T8161-V02 ; T8162-V02 ; T8175-V02 ; T8261-V02 ; T8273-V01 ; T8276-V01 ; T8277-V01 ; T8280-V01 ; T8281-V01 ; T8283-V01 ; T8285-V01 ; T8286-V01 ; T8289-V01 ; T8291-V01 ; T8297-V02 ; T8299-V02 ; T8304-V02 ; T8305-V02 ; T8309-V02 ; T8310-V02 ; T8312-V02 ; T8313-V02 ; T8389-V01 ; T8390-V01 ; T8392-V01 ; T8398-V01 ; T8403-V02 ; T8409-V02 ; T8410-V02 ; T8413-V02 ; T8416-V02 ; T8417-V02 ; T8418-V02 ; T8422-V02 ; T8425-V02 ; T8426-V01 ; T8428-V02 ; T8432-V02 ; T8434-V02 ; T8442-V02 ; T8456-V01 ; T8460-V01 ; T8462-V01 ; T8466-V01 ; T8472-V01 ; T8473-V01 ; T8497-V02 ; T8517-V02 ; T8518-V02 ; T8578-V02 ; T8581-V02 ; T8590-V02 ; T8600-V01 ; T8603-V01 ; T8605-V01 ; T8606-V01 ; T8612-V01 ; T8660-V02 ; T8662-V02 ; T8675-V02 ; T8682-V01 ; T8685-V01 ; T8688-V01 ; T8689-V01 ; T8692-V01 ; T8693-V01 ; T8713-V02 ; T8715-V02 ; T8716-V02 ; T8730-V02 ; T8732-V02 ; T8734-VO2 ; T8736-V02 ; T8738-V02 ; T8746-V01 ; T8758-V01 ; T8763-V01 ; T8764-V01 ; T8770-V01 ; T8798-V01 ; T8869-V01 ; T8870-V01 ; T8876-V02 ; T8881-V02 ; T8933 ; T9193-V01 ; T9279-V01 ; T9291-V02 ; T9293-V02 ; T9304-V01 ; T9315-V01 ; T9324-V02 ; T9340-V02 ; T9343-V02 ; T9350-V02 ; T9354-V02 ; T9549-V02 ; T9562-V02 ; T9575-V02 ; T9578-V02 ; T9585-V02 ; T9588-V02 ; T9593-V01 ; T9600-V01 ; T9604-V01 ; T9726-V02 ; T9730-V02 ; T9731-V02 ; T9736-V02 ; T9739-V02 ; T9743-V02 ; T9744-V02 ; T9773-V02 ; T9778-V02 ; T9882-V02 ; T9885-V02 ; T9910-V01 ; T9917-V01 ; T9953-V02 ; A0087-V01 ; A0236-V01 ; A0401-V02 ; A0408-V02 ; A0425-V01 ; A0463-V02 ; A1305-V02 ; A1345-V02 ; A1649-V02 ; A2032-V01 ; A2462-V02 ; a2465-v01 ; A278-V01 ; A3178-V02 ; A3375-V01 ; A3992-V01 ; A4589-V02 ; A4652-V02 ; A4719-V02 ; A4720-V02 ; A4724-V02 ; A4728-V02 ; A4730-V02 ; A4733-V02 ; A5905-V01 ; A5907-V01 ; A5911-V01 ; A5921-V02 ; A5922-V02 ; A5930-V02 ; A5931-V02 ; A5932-V02 ; A5933-V02 ; A5934-V02 ; A5937-V02 ; A5938-V02 ; A5942-V02 ; A5946-V02 ; A5950-V02 ; A5951-V02 ; A5953-V02 ; A5954-V02 ; A5958-V02 ; A6033-V02 ; A6045-V02 ; A6046-V02 ; A6047-V02 ; A6065-V01 ; A6074-V02 ; A6076-V02 ; A6081-V02 ; A6238-V02 ; A6244-V02 ; A6246-V02 ; A6249-V02 ; A6254-V02 ; A6261-V01 ; A6263-V01 ; A6265-V01 ; A6268-V01 ; A6270-V01 ; A6427-V02 ; A6428-V02 ; A6429-V02 ; A6430-V02 ; A6431-V02 ; A6432-V02 ; A6445-V01 ; A6446-V01 ; A6447-V01 ; A6449-V01 ; A6451-V01 ; A6452-V01 ; A6454-V01 ; A6456-V01 ; A6457-V01 ; A6458-V01 ; A6460-V01 ; A6478-V02 ; A6482-V02 ; A6485-V02 ; A6495-V02 ; A6496-V02 ; A6501-V02 ; A6503-V02 ; A6504-V02 ; A6505-V02 ; A6506-V02 ; A6507-V02 ; A6508-V02 ; A6510-V02 ; A6511-V02 ; A6512-V02 ; A6513-V02 ; A6514-V02 ; A6519-V02 ; A6520-V02 ; A6521-V02 ; A6522-V02 ; A6523-V02 ; A6524-V02 ; A6725-V01 ; A6727-V01 ; A6728-V01 ; A6730-V01 ; A6731-V01 ; A6732-V01 ; A6733-V01 ; A6734-V01 ; A6735-V01 ; A6737-V01 ; A6738-V01 ; A6739-V01 ; A6740-V01 ; A6877-V01 ; A6878-V01 ; A6879-V01 ; A6881-V01 ; A6885-V01 ; A6887-V01 ; A6889-V01 ; A6890-V01 ; A6891-V01 ; A7116-V02 ; A7125-V02 ; A7126-V02 ; A7133-V02 ; A7135-V02 ; A7137-V02 ; A7138-V02 ; A7139-V02 ; A7140-V02 ; A7141-V02 ; A7175-V01 ; A7176-V01 ; A7177-V01 ; A7178-V01 ; A7179-V01 ; A7180-V01 ; A7181-V01 ; A7182-V01 ; A7387-V01 ; A7396-V01 ; A7400-V01 ; A7406-V01 ; A7408-V01 ; A7409-V01 ; A7410-V01 ; A7414-V01 ; A7420-V01 ; A7426-V01 ; A7428-V01 ; A7429-V01 ; A7430-V01 ; A7431-V01 ; A7432-V01 ; A7433-V01 ; A7434-V02 ; A7435-V02 ; A7437-V02 ; A7438-V02 ; A7439-V02 ; A7442-V02 ; A7443-V02 ; A7450-V02 ; A7451-V02 ; A7452-V02 ; A7456-V02 ; A7457-V02 ; A7458-V02 ; A7459-V02 ; A7460-V02 ; A7461-V02 ; A7463-V02 ; A7464-V02 ; A7465-V02 ; A7466-V02 ; A7467-V02 ; A7468-V02 ; A7472-V02 ; A7473-V02 ; A7868-V01 ; A7869-V01 ; A7875-V01 ; A7876-V01 ; A7877-V01 ; A7878-V01 ; A7977-V01 ; B0030-V02 ; B0109-V02 ; B0299-V02 ; B0304-V02 ; B0307-V02 ; B0310-V02 ; B0311-V02 ; B0312-V02 ; B0313-V02 ; B0314-V02 ; T0476-V0-2 ; T0752-V01 ; T0985-V02 ; T0988 ; T1145-V01 ; T1330-V01 ; T1344-V02 ; T1449-V01 ; T1519 ; T1563-V01 ; T1838-V01 ; T1840 ; T1991-V02 ; T2078-V01 ; T2291-V02 ; T2398-V01 ; T2433-VO2 ; T2446-V02 ; T2525-V01 ; T2937 ; T2953 ; T2964-V01 ; T2969-V01 ; T4176-V02 ; t4358-v01 ; T4370-V01 ; T4377-V01 ; T4384 ; T4465-V02 ; T4558-V02 ; T4582-V02 ; T4799-V01 ; T5230-V02 ; T5388-V02 ; T5390 ; T5439-V01 ; T5449-V01 ; T5561-V02 ; T6012-V01 ; T6042-V02 ; T6237-V02 ; T6443-V01 ; T6481-V02 ; T6841-V01 ; T6912 ; T6931-V02 ; T7079-V02 ; T730--V02 ; T7930-V01 ; T8111-V01 ; T8288-V01 ; t8458-v01 ; T8673-V01 ; T8684-V01 ; T8717-V02 ; T8739-V02 ; T8771-V01 ; T8779-V01 ; T8889-V02 ; T9232-V01 ; T9292-V02 ; T9295-V02 ; T9314-V01 ; T9570-V02 ; T9786-V01.
RECALLING FIRM/MANUFACTURER
Power Surgical Solutions, Fort Worth, TX, by letter on November 11, 2004. Firm initiated recall is ongoing.
REASON
Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping.
VOLUME OF PRODUCT IN COMMERCE
1,432 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-0297-05.
CODE
All systems using software version 3.09.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated November 5, 2004. Firm initiated recall is ongoing.
REASON
Test results may be adversely affected by software shutting down the cooling blocks in systems with software versions 3.09.
VOLUME OF PRODUCT IN COMMERCE
65.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
CryoValve, Pulmonary Valve and Conduit. Recall # Z-0298-05.
CODE
Dibir # 75387, Serial #8235992, Model #PV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by verbally on July 28, 2004. Firm initiated recall is complete.
REASON
The tissue donation was deferred due to possible Hepaititis C suspected by the MD.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Recall # Z-0299-05.
CODE
Serial numbers 200101 to 202190.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., Mc Graw Park, IL, by letters dated December 2, 2004. Firm initiated recall is ongoing.
REASON
The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.
VOLUME OF PRODUCT IN COMMERCE
3,004 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48inch); a sterile set consisting of a bag connector (spike connector) on-off clamp assembly, tubing and double scaling male Luer lock connector; product code R5C4325. Recall # Z-0301-05.
CODE
Lot H03L12057, expiration date 12/31/08.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., Mc Graw Park, IL, by letter dated November 5, 2004. Firm initiated recall is ongoing.
REASON
Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.
VOLUME OF PRODUCT IN COMMERCE
1,152 sets.
DISTRIBUTION
Internationally.

_______________________________
PRODUCT
a) NAMIC Custom Angiographic Kit, Left Heart Kit-
Model #H749651947220. Catalog # 65194722.
Recall # Z-0302-05;
b) NAMIC Custom Angiographic Kit, Left Heart Kit.
Model #H7496019054110. Catalog # 601905411.
Recall # Z-0303-05.
CODE
a) Lot #990024;
b) Lot #988046.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp, Glens Falls, NY, by telephone on October
21, 2004 and October 22, 2004, and by letters dated November 17,
2004. Firm initiated recall is ongoing.
REASON
The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub.
VOLUME OF PRODUCT IN COMMERCE
154 kits.
DISTRIBUTION
IL and NV.

_______________________________
PRODUCT
a) Genesis Uni Articular Inserts. Recall # Z-0304-05;
b) Tibial Base Plates. Recall # Z-0305-05.
CODE
a) Lot numbers: 71248108, 71248109, 71248110,
71248111, 71248112, 71248208, 71248209,
71248210, 71248211, 71248212, 71248308,
71248309, 71248310, 71248311, 71248312,
71248228, 71248229, 71248230, 71248231,
71248232, 71248235, 71248328, 71248329,
71248330, 71248331, 71248332, 71248335,
71248338, 71248339, 71248340, 71248341,
71248342, 71248345 Sold internationally:
71975865, 71975866, 71975867, 71975870,
71975871, 71975872, 71975873.
b) Tibial Base Plates 726100, 726101, 727100,
727101, 726202, 726203, 727202, 727203,
726304, 726305, 727304, 727305.
RECALLING FIRM/MANUFACTURER
Smith & Nephew Inc., Memphis, TN, by letter and email on June 21, 2004. Firm initiated recall is ongoing.
REASON
The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
VOLUME OF PRODUCT IN COMMERCE
11,339 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. Recall # Z-0360-05.
CODE
All serial numbers are affected by this recall action. Serial numbers range from 1003 to 1092.
RECALLING FIRM/MANUFACTURER
Coherent, Inc., Santa Clara, CA, by letters on March 30, 2004. Firm initiated recall is ongoing.
REASON
Software problem that may cause unintended emission of laser radiation.
VOLUME OF PRODUCT IN COMMERCE
75 units.
DISTRIBUTION
NC, Canada, Germany, and Japan.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Intinion 1.5 T MRI Scanner. Recall # Z-0272-05.
CODE
Serial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter, dated April 17, 2003. Firm initiated recall is ongoing.
REASON
There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.
VOLUME OF PRODUCT IN COMMERCE
172 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Straumann Dental Implant System, SP Profile Drill, Short, 04-2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084. Recall # Z-0300-05.
CODE
Lot Numbers: 1300 and 1301.
RECALLING FIRM/MANUFACTURER
The Straumann Company, Waltham, MA, by letter dated November 11,
2004. Firm initiated recall is ongoing.
REASON
Outside label incorrectly identifies drill as Regular Neck (RN) instead of Wide Neck (WN).
VOLUME OF PRODUCT IN COMMERCE
85 units.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR December 22, 2004

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