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 17, 2008
08-50

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Harold's Dangerously Hot Grillin' Sauce in 16 oz glass bottle w/black plastic screw on lid w/preprinted sticker on label, CaJohns Fiery Foods, Columbus, OH 43224, UPS code: 647293002498, Recall # F-053-9
CODE
All units in batch codes: 249242, 249298, 249304, 249154, 249181 & 249197
RECALLING FIRM/MANUFACTURER
CaJohns Fiery Foods Company, Columbus , OH , by telephone on September 11, 12 &15, 2008, by press release on September 24, 2008, and by letters on October 30, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared fish, soy, and wheat.
VOLUME OF PRODUCT IN COMMERCE
755 bottles
DISTRIBUTION
NJ, NY, OH, PA, Canada & Germany

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
H.I. Shitake Dried Mushroom, sold in 3 oz acrylic plastic bag, UPC Number: 0 45027 27488 1, Recall # F-051-9
CODE
No lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hocean Inc., City Of Commerce , CA , by letters and telephone on November 5, 2008.
Manufacturer: Xiamen Sunmore Food Corporation Limited, Xiamen , China . Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites based on the State of Florida 's analysis.
VOLUME OF PRODUCT IN COMMERCE
200 cases (3 oz X 100 bags/case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Caravelle Brand Dried Shallots (Hanh Say Kho), in 14 ox cellophane bags, UPC #: 0 80736 10996 3, Recall # F-052-9
CODE
No lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Anhing Corporation, Los Angeles , CA , by letter on November 13, 2008.
Manufacturer: nam phong food factory, ho chi minh city , Vietnam . Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites based on the State of Florida 's analysis.
VOLUME OF PRODUCT IN COMMERCE
153 cartons (30 X 14 oz packages/carton)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
(Packaged under Preferred Plus label): Earwax Removal Aid, Carbamide Peroxide 6.5%, non USP, Cleanses Ear with Microfoam Action, 0.5 fl. oz. (15 mL), NDC 66879-915-01; Pharmacist Recommended, Earwax Removal Aid, Carbamide Peroxide 6.5%, non USP, Cleanses Ear with Microfoam Action, 1 fl. oz. (30 mL), NDC 11383-172-01, Recall # D-040-2009
CODE
Lot: H07070, Exp. 8/09; Lot : 07080A1, Exp. 8/09
RECALLING FIRM/MANUFACTURER
Medico Labs, Inc., Hamilton , NJ , by letters on December 1, 2008. Firm initiated recall is ongoing.
REASON
Failing results for pH of stability samples.
VOLUME OF PRODUCT IN COMMERCE
11,784 bottles
DISTRIBUTION
NY, IA
___________________________________
PRODUCT
Qualitest®, Butalbital and Acetaminophen Tablets, 50mg/325mg, 100 Tablets, Rx only, NDC 0603-2540-21, Recall # D-139-2009
CODE
Lot B080073A, exp 3/13/11
RECALLING FIRM/MANUFACTURER
Mikart Inc., Atlanta , GA , by telephone on October 23, 2008 and a follow- up letter on October 27, 2008. Firm initiated recall is on going.
REASON
May contain some low weight tablets.
VOLUME OF PRODUCT IN COMMERCE
4,880 x 100 count tablet bottles
DISTRIBUTION
AL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Plasma Frozen, Recall # B-0262-09
CODE
Unit: 4351652
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center , Shrewsbury , NJ , by telephone on December 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Scotland
___________________________________
PRODUCT
Source Plasma, Recall # B-0268-09
CODE
Units: JQ053659, JQ048439, JQ048036, JQ047316, JQ046875, JQ037503, JQ037110, JQ036862, JQ036444, JQ036147, JQ035623, JQ035420
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson , TN , by fax on April 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0272-09;
b) Red Blood Cells, Recall # B-0273-09
CODE
a) and b) Unit: 4040269
RECALLING FIRM/MANUFACTURER
HemaCare Corp., Van Nuys , CA , by letter on September 21, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for sexual contact with an individual who lived in an HIV-Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0274-09
CODE
Unit: 8800567
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota , FL , by telephone and fax on February 22, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the drug Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0277-09;
b) Platelets Leukocytes Reduced, Recall # B-0278-09
CODE
a) and b) Unit: 16LK47885
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone and email on October 18, 2007 and follow-up letter on October 26, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Platelets, Recall # B-0279-09
CODE
Unit: 9068214
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by telephone on January 22, 2008 and by follow-up letter on January 29, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0280-09
CODE
Unit: 72E900446
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville , FL , by fax on January 25, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0281-09
CODE
Unit: 72E83305X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville , FL , by fax on February 8, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis), Recall # B-0289-09
CODE
Units: 6699084, 6699137
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota , FL , by telephone on January 11, 2005. Firm initiated recall is complete.
REASON
Blood products, for which quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0291-09
CODE
Unit: 2218598
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center , Tallahassee , FL , by letter dated June 9, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0298-09
CODE
Unit: LE28216
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling , VA , by letter on January 14, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0304-09;
b) Platelets, Recall # B-0305-09
CODE
a), and b) Unit: LN23729
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling , VA , by fax on January 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0306-09
CODE
Unit: KS69313
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling , VA , by fax on October 16, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0309-09
CODE
Unit: 72F155396
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville , FL , by facsimile on March 26, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0310-09
CODE
Unit: 7712173
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota , FL , by telephone on February 16, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Hepatitis A, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0312-09
CODE
Unit: 7966019
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by telephone on July 17, 2007. Firm initiated recall is complete.
REASON
Blood product, collected in an apheresis collection kit that had exceeded the acceptable time period for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0275-09
CODE
Unit: 16KS07702
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on July 18, 2007 and follow-up letter on July 19, 2007. Firm initiated recall is complete.
REASON
Blood product, prepared without the appropriate amount of additive (Adsol), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0276-09
CODE
Unit: 16LK47885
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone and email on October 18, 2007 and follow-up letter on October 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0283-09;
b) Platelets, Pheresis, Leukocytes Reduced, Recall # B-0284-09;
c) Red Blood Cells (Apheresis), Leukocytes Reduced, Recall # B-0285-09;
d) Platelets, Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0286-09;
e) Plasma, Frozen, Recall # B-0287-09
CODE
a) Units: 38KF22727, 38W56600, 38W56610, 38FH57784, 38FK55888, 38FK55891, 38FH57781, 38GZ24586, 38GZ24605, 38GZ24612, 38GZ24584, 38GZ24590, 38KF22738, 38W56621, 38W56617, 38KW53102, 38KW53110, 38KW53128, 38KW53098, 38KW53100, 38KW53117, 38W56606, 38KW53091, 38KW53107, 38KW53108, 38FH57769, 38KF22724, 38KF22735, 38W56625, 38E32557, 38W56618, 38W56613, 38W56604, 38GZ24607, 38GZ24579, 38KF22734, 38GZ24591, 38GZ24592, 38FH57774, 38KW53126, 38GZ24620, 38GZ24621, 38KW53120, 38KW53121, 38KW53106, 38KW53099, 38KW53130, 38KW53125, 38W56614, 38KW53119, 38GZ24614, 38GZ24616, 38W56626, 38W56627, 38E32554, 38GZ24626, 38FH57776, 38KF22730, 38KF22736, 38KF22720, 38FK55899, 38KT78663, 38W56623, 38W56628, 38FH57777, 38KF22728, 38KF22729, 38KF22732, 38KF22723, 38E32555, 38E32559, 38GP37423, 38C60989, 38C60990, 38C61003, 38KW53114, 38KT78662, 38E32560, 38W56624, 38KT78659, 38KF22717, 38KF22719, 38LJ03594, 38KF22726, 38W56611, 38W56612, 38W56620, 38KW53134, 38KW53133, 38KW53132, 38W56601, 38W56602, 38E32556;

b) Units: 38FX26097 (Parts 1, 2, & 3), 38LJ03593 (Part 1), 38FX26084 (Part 1), 38FX26083 (Parts 1 & 2), 38FX26089 (Parts 1 & 2), 38FX26086 (Parts 1 & 3), 38FX26081 (Parts 1 & 2), 38FX26094 (Parts 1 & 2), 38GP37422 (Parts 1, 2, & 3), 38GP37418 (Parts 1, 2, & 3), 38FX26095 (Parts 1, 2, & 3), 38FX26090 (Parts 2 & 3), 38FX26092 (Parts 2 & 3), 38GP37424(Parts 1 & 2), 38FX26088 (Parts 1 & 2), 38GP37426 (Parts 1 & 2), 38FX26082 Parts 1 & 2), 38GP37417 (Parts 1 & 2), 38GP37420 (Parts 1 & 2), 38FX26096 (Parts 2 & 3), 38GP37427 (Part 1);

c) Units: 38GZ24600 (Bags 1 & 2), 38GZ24593 (Bags 1 & 2), 38GZ24595 (Bags 1 & 2), 38GZ24594 (Bags 1 & 2), 38GZ24601 (Bags 1 & 2), 38GZ24609 (Bags 1 & 2), 38GZ24602 (Bags 1 & 2), 38GZ24606 (Bags 1 & 2), 38GZ24625 (Bags 1 & 2), 38GZ24603 (Bags 1 & 2), 38C60995 (Bags 1 & 2), 38GZ24596 (Bags 1 & 2), 38GZ24599 (Bags 1 & 2), 38GZ24598 (Bags 1 & 2);

d) Units: 38FX26090, 38FX26092, 38FX26091, 38FX26096;

e) Units: 38GZ24575, 38KF22718
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne , IN , by telephone on June 18, 2008 or by facsimile on July 3, 2008. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for West Nile Virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
170 units
DISTRIBUTION
IN, OH and TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0288-09
CODE
Unit: W03940851883900
RECALLING FIRM/MANUFACTURER
Florida Blood Service, Inc., St. Petersburg, FL, by telephone on July 16, 2008 and by facsimile on July 17, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not properly determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-0290-09
CODE
Unit: 2026171
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center , Tallahassee , FL , by letter dated December 14, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not frozen within eight hours of collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0311-09
CODE
Unit: 2024500
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center , Tallahassee , FL , by letter dated November 21, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Propecia, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, 30 mg/mL fill size, Recall # Z-0343-2009
CODE
Lot Number: UD30654
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana , CA , by letters on October 30, 2008.
Manufacturer: Pharmacia Diagnostics AB, Uppsala , Sweden . Firm initiated recall is ongoing.
REASON
Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS in patients following surgery.
VOLUME OF PRODUCT IN COMMERCE
1450 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Gravity Compensating Accessory; High Pressure Range , Sterile, Single Use, Rx only. CSF shunt accessory. The GCA is an implantable device designed to be used in conjunction with implanted systems which. shunt cerebrospinal fluid CSF from the cerebral ventricles to an appropriate drainage site a) Catalog number: 903-430, b) Catalog Number 903-435, c) Catalog Number 903-440, Recall # Z-0458-2009
CODE
a) Lot Numbers 148792, 149247; b) Lot Numbers 147796, 148790; and c) Lot Numbers 147795, 149246
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro , NJ , by letters dated October 3, 2008.
Manufacturer: Integra Neurosciences Implants S.A., Sophia Antipolis, France. Firm initiated recall is ongoing.
REASON
Product has the potential for CSF leakage under certain conditions.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
Nationwide, Carnegie , Victoria , Melbourne , Australia

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. REF 195240. Level Sensor pads are used to attach the level sensor to the sides of a rigid reservoir, Recall # Z-0311-2009
CODE
Lot Number 78925
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor , MI , by letter dated February 13, 2008. Firm initiated recall is ongoing.
REASON
The level sensor holder may detach from the adhesive pad causing the sensor to lose contact with the venous reservoir, which may result in a detached sensor indication or false alarm.
VOLUME OF PRODUCT IN COMMERCE
31,980 units
DISTRIBUTION
Nationwide, Australia , Belgium , Canada , China , Dominican Republic , Japan , Saudi Arabia , Singapore and Yemen
___________________________________
PRODUCT
a) Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, Recall # Z-0354-2009;

b) Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump; Model 801041). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, Recall # Z-0355-2009;

c) Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, Recall # Z-0356-2009;

d) Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump, Gray; Model 816571). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, Recall # Z-0357-2009
CODE
a) Serial numbers 0028 through 0111, 0113 through 0527, 0700 through 1528, 1539 through 1579, 2000 through 2392 and 2395 through 2466;

b) Serial numbers 0030, 0032 through 0587, 0700 through 1936, 1947 through 1951 and 2000 through 2799;

c) Serial numbers 1001 through 1008 and 4009 through 4269;

d) Serial numbers 1001 through 1008 and 4009 through 4414
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor , MI , by letter dated July 18, 2008. Firm initiated recall is ongoing.
REASON
Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.
VOLUME OF PRODUCT IN COMMERCE
5116 units
DISTRIBUTION
Nationwide, Australia , Belgium . Canada, Columbia, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam
___________________________________
PRODUCT
a) Mentor Aseptic Transfer Set, Cat. #350-8400, b) contains BD 60mL Luer-Lok Syringe, Reorder Number: 309653, Recall # Z-0407-2009
CODE
a) All lots.
b) Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mentor Texas, Inc., Irving , TX , by letter on August 18, 2008.
Manufacturer: Becton Dickinson & Company, Franklin Lakes , NJ. Firm initiated recall is ongoing.
REASON
The Mentor Aseptic Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under recall by Becton Dickinson due to a package integrity issue.
VOLUME OF PRODUCT IN COMMERCE
32,480 sets
DISTRIBUTION
Nationwide (except Alaska ), PR, Australia , Canada , Costa Rica , Korea , New Zealand and South Africa
___________________________________
PRODUCT
Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit. Intended Use: The dual heated adult respiratory ventilator circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of the humidified gas, to reduce condensation, Recall # Z-0414-2009
CO DE
All lot numbers up to and including Lot 080627
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fisher & Paykel Healthcare Inc., Huntington Beach , CA , by letters dated October 8, 2008.
Manufacturer: Fisher & Paykel Electronics, Ltd, Auckland , New Zealand . Firm initiated recall is ongoing.
REASON
The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in excess of the specified seven-day maximum duration of use, which may increase the risk of malfunction or fire.
VOLUME OF PRODUCT IN COMMERCE
229,320 units
DISTRIBUTION
Nationwide and Canada
__________________________________
PRODUCT
a) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm, 10cc, Sterile EO. Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding, Recall # Z-0416-2009;

b) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm, 10cc, Sterile EO. Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for internal feeding, Recall # Z-0417-2009;

c) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm, 10cc, Sterile EO. Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding, Recall # Z-0418-2009;

d) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00203W, 20F, 1.2cm, 10cc, Sterile EO. Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding, Recall # Z-0419-2009;

e) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc, Sterile EO, Recall # Z-0420-2009;

f) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00205W, 20F, 2.4cm, 10cc, Sterile EO, Recall # Z-0421-2009;

g) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00206W, 20F, 3.4cm, 10cc, Sterile EO, Recall # Z-0422-2009;

h) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00207W, 20F, 4.4cm, 10cc, Sterile EO, Recall # Z-0423-2009;

i) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00209W, 16F, 1.7cm, 20cc, Sterile EO, Recall # Z-0424-2009;

j) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00210W, 16F, 2.4cm, 20cc, Sterile EO, Recall # Z-0425-2009;

k) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00212W, 20F, 1.7cm, 20cc, Sterile EO, Recall # Z-0426-2009;

l) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00213W, 20F, 2.4cm, 20cc, Sterile EO, Recall # Z-0427-2009;

m) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00214W, 20F, 3.4cm, 20cc, Sterile EO, Recall # Z-0428-2009;

n) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00215W, 20F, 4.4cm, 20cc, Sterile EO, Recall # Z-0429-2009;

o) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00216W, 24F, 1.7cm, 20cc, Sterile EO, Recall # Z-0430-2009;

p) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00217W, 24F, 2.4cm, 20cc, Sterile EO, Recall # Z-0431-2009;

q) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00218W, 24F, 3.4cm, 20cc, Sterile EO, Recall # Z-0432-2009;

r) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00219W, 24F, 4.4cm, 20cc, Sterile EO, Recall # Z-0433-2009;

s) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00221W, 18F, 1.2cm, 10cc, Sterile EO, Recall # Z-0434-2009;

t) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00222W, 18F, 1.7cm, 10cc, Sterile EO, Recall # Z-0435-2009;

u) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00223W, 18F, 2.4cm, 10cc, Sterile EO, Recall # Z-0436-2009;

v) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00224W, 18F, 3.4cm, 10cc, Sterile EO, Recall # Z-0437-2009;

w) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00225W, 18F, 4.4cm, 10cc, Sterile EO, Recall # Z-0438-2009
CODE
a) 43AOA018, 43AOA041, 43APA032, 43BOA015, 43BOA037, 43BPA025, 43BQA042, 43BQA184, 43COA013, 43COA036, 43CQA232, 43DOA010, 43DOA037, 43DPAO14, 43DQA063, 43EOA0 13, 43EOA041, 43EPAO13, 43EPA040, 43FOA076, 43FOA107, 43FOA234, 43GOA033, 43GOA009, 43GPA177R, 43GPA178R, 43GPA190R, 43GPA195R, 43HOA031, 43HPA018, 43HPA050, 43HPA223R, 43INA031, 43IOA038, 43IPA017R, 43IPA207R, 43IQA001, 43JNAOO1, 43JNAO44, 43JNA203, 43JNA219, 43JOA014, 43JPA013, 43JPA036, 43KNA012, 43KNA053, 43KOA016, 43KPA013, 43LNAO22, 43LNAO52, 43LOA023, 43LQA001, HURB2525, HURB3526, HURD1915, HURF0483, HURG1443, HURH1078, HURJ0571, HURB2422, HURD0734, HURE0535, HURE2889, HURG1444, and HURJ0594;

b) 43AOA019, 43LNA053, 43AOA042, 43LOA024, 43APA033, 43LPA008, 43ARAOO2, 43LQAO29, HURA1265, 43BOA016, HURB2526, 43BOA038, HURB4356, 43BQA043, HURB4357, 43COA014, HURD1917, 43COA037, HURF0484, 43DOA011, HURG1445, HURH1079, HURJ0002, 43DOA038, 43DOA203, 43DPA015, HURJ0595, 43DPA044, HURJ1549, 43DPA204, HURK1491, 43DPA205, HURB2425, 43DQA064, HURB4421, 43EOA014, HURD1916, 43EOA042, HURE2890, 43EPA014, HURF0485, 43EPAO41, HURH0242, 43EPA209, HURH1080, 43EPA216, HURJ1557, 43EQA009, 43FOA077, 43FOA108, 43GOA034, 43GPA179R, 43GPA180R, 43GQA001, 43GQA032, 43HPA019R, 43HPA192, 43HPA225R, 43HQA001, 43HQA165, 43INA032, 43IOA039, 43IPAO18, 43IPA041, 43IPA199R, 43IQA002, 43JNA002, 43JNA045, 43JNA204, 43JOA015, 43JPA014, 43JPA037, 43JQA001, 43JQA027, 43KPA014, 43KQA001, 43KQA027, and 43LNA023;

c) 43AOA020, 43AOA012, 43APA014, 43JQA028, 43APA034, 43KNA054, 43KPA015, 43ARA030, 43KQA028, 43BOA017, 43LNA024, 43BPA010, 43LNA054, 43BQA007, 43LOA009, 43BQA044, 43LOA025, 43COA015, 43LPA112, 43CPA014, 43LQA003, 43CQA015, 43LQA030, 43CQA234, HURA1274, HURB2527, 43DOA012, HURB4359, 43DPA016, HURB4563, 43DPA045, HURD1919, 43DPA206, HURE2891, 43DQA009, HURF0487, 43EOA015, HURG1446, 43EOA043, HURH1082, 43EPAO15, HURJ0005, 43EPA042, 43EPA217, HURJ0597, 43EQA010, HURCA095, 43FOA078, HURE2892, 43FOA109, HURF0486, 43FOA229, HURG1447, 43FQA001, HURH1081, 43GOA011, HURJ0598, 43GPA147, HURJ1559, 43GPA148, 43GPA196R, 43GPA230R, 43GPA231R, 43GQA002, 43GQA033, 43HOA033, 43HPA020, 43HPA051, 43HQA002, 43HQA155, 43HQA163, 43IOA013, 43IOA040, 43IPA019, 43IPA212, 43IPA213, 43IQA003, 43JNA003, 43JOA016, 43JPA015, 43JPA193, and 43JQA002;

d) 43AOA043, 43BOA018, 43BQA045, 43BQA156, 43COA016, 43COA038, 43CQA016, 43CQA235, 43DOA013, 43DPA017, 43DPA207, 43DQA010, 43DQA065, 43EOA016, 43EOA044, 43EPA016, 43EPA043, 43EQA011, 43EQA182, 43FOA110, 43FOA230, 43GPA184R, 43GPA185R, 43GPA186R, 43GPA187R, 43GPA220R, 43GPA221R, 43GQA034, 43HPA052R, 43HQA003, 43lNA034, 43IOA014, 43IPA020, 43JOA017, 43JPA016, 43KQA029, 43LOA026, 43LQA004, 43LQA031, HURB2529, HURD0665, HURD1920, HURJ0599, HURK1509, HURB2427, HURE2894, HURH1083,and HURJ0600;

e) 43APA035, 43ARA005, 43BOA039, 43BQA008, 43BQA046, 43COA017, 43COA039, 43CQA017, 43CQA236, 43DOA014, 43DPA208, 43DPA209, 43DQA011, 43EOA017, 43EOA045, 43EPA017, 43EPA044, 43EPA210, 43FOA080, 43FOA111, 43FQA002, 43GPA174R, 43GPA175R, 43GPA192R, 43GQA003, 43HOA034, 43HPA021R, 43HPA053R, 43HQA004, 43INA014, 43IOA041, 43IPA021R, 43IPA043R, 43IQA004, 43JNA004, 43JNAO47, 43JNA206, 43JOA018, 43JPA017, 43JPA038, 43JQA003, 43KNA015, 43KOA017, 43KPA016, 43KPA056, 43KQA003, 43KQA030, 43LNA055, 43LOA027, 43LPA009, 43LPA039, 43LQA005, 43LQA032, HURB3524, HURB4420, HURD1921, HURG1448, HURH1084, HURJ0602, HURK1510, HURB2428, HURD0505, HURE2896, and HURJ0601;

f) 43AOA021, 43AOA044, 43APA036, 43ARA284, 43BOA020, 43BOA021, 43BPA011, 43BPA026, 43BQA047, 43BQA185, 43CPA016, 43CPA196, 43CQA018, 43CQA019, 43CQA020, 43DPA018, 43DPA019, 43DPA046, 43DPA210, 43DQA012, 43DQA066, 43EOA018, 43EOA019, 43EPA018, 43EPA045, 43EPA211, 43EPA214, 43EQA012, 43EQA013, 43EQA051, 43EQA206, 43FOA081, 43FOA082, 43FOA083, 43FOA084, 43FOA085, 43FOA112, 43FOA233, 43FQA039, 43GOA014, 43GOA015, 43GPA197R, 43GPA237R, 43GQA004, 43HPA022, 43HPA023, 43HPA054, 43HQA005, 43HQA006, 43HQA031, 43HQA156, 43INA015, 43INA036, 43IOA016, 43IOA017, 43IOA042, 43IPA022, 43IPA044, 43IPA208R, 43IQA005, 43IQA029, 43JNA005, 43JPA018, 43JPA019, 43JPA039, 43JQA004, 43KNA016, 43KNA055, 43KOA011, 43KOA018, 43KPA017, 43KQA004, 43KQA031, 43LNA025, 43LOA028, 43LQA006, 43LQA033, HURA1293, HURB3527, HURD0567, HURD1924, HURD1925, HURE2898, HURE2899, HURE2900, HURF0491, HURG0212, HURG1015, HURG1449, HURG1450, HURH1086, HURH1087, HURI0668, HURI0677, HURJ0892, HURJ1573, HURK1261, HURB2429, HURB2430, HURCA647, HURD1922, HURE2901, HURF0492, HURH1088, HURI0866, HURJ0603, and HURK1511;

g) 43A0A022, 43A0A023, 43APA037, 43ARA007, 43BOA022, 43BOA175, 43BPA012, 43BQA162, 43BQA163, 43BQA164, 43COA019, 43COA211, 43CPA017, 43CPA018, 43CQA02 I, 43CQA022, 43CQA023, 43DOA018, 43DPA020 43DPA02 I, 43DPA022, 43DPA211, 43 DPA212, 43DQA014, 43DQA015, 43DQA017, 43EPA019, 43EPA046, 43EPA212, 43EPA215, 43EPA227, 43EQA052, 43FOA086, 43FOA087, 43FOA088, 43GOA016, 43GOA017, 43GOA035, 43GPA149, 43GPA198R, 43GPA199R, 43GPA233R, 43GQA007, 43GQA008, 43GQA009, 43HPA024, 43HPA025, 43HQA007, 43HQA008, 43HQA158, 43 INA016, 43INA037, 43INA223, 43IOA018, 43IOA019, 43IOA020, 43IOA181, 43 IPA023, 43IPA024, 43IPA045R, 43IQA006, 43IQA007, 43IQA030, 43JOA019, 43JPA020, 43JPA040, 43JQA005, 43JQA006, 43JQA030, 43JQA151, 43JQA154, 43KNA017, 43KNA056, 43KOA012, 43KOA019, 43KPA018, 43KPA189, 43KQA005, 43KQA006, 43KQA032, 43LNA026, 43LNA056, 43LOA029, 43LPA010, 43LQA007, 43LQA034, HURA1302, HURA1309, HURB2533, HURD0568, HURD1926, HURD1927, HURE2902, HURE2903, HURE2904, HURF0493, HURF0494, HURF0495, HURG1451, FIURG1452, HURH0004, HURH1089, HURH1090, HURI0669, HURI0678, HURJ1579, HURJ1582, HURK0006, HURK1262, HURK15I2, HURL0023, HURA1315, HURC9665, HURCA105, HURJ1150, HURJ1577, and HURL0228;

h) 43APA015, 43APA038, 43ARA285, 43ARA290, 43BOA023, 43BPA013, 43COA020, 43CQA025, 43DOA022, 43DPA023, 43DPA047, 43DPA225, 43DQA018, 43EQA018, 43EQA053, 43EQA205, 43FOA090, 43FPA177, 43GOA018, 43GPA150, 43GPA200R, 43GQA011, 43GQA191, 43HOA017, 43HOA035, 43HPA026, 43HPA027, 43HQA009 43INA017, 43INA038, 43IOA021, 43I0A043, 43IPA025, 43IPA046, 43IPA200R, 43IQA008, 43IQA031, 43JNA006, 43JNA048, 43JOA004, 43JOA020, 43JPA021, 43JPA041, 43JQA007, 43KNA018 43KNA057, 43KOA020, 43KPA019, 43KQA033, 43LNA027, 43LOA010, 43LOA030, 43LOA008, HURA1321, HURB2536, HURB4365, HURB4366, HURD0671, HURD0672, HURD1928, HURE2906, HURF0496, HURG1454, HURH1091, HURJ0604, HURJ1586, HURK1513, and HURE2905;

i) 43BOA040, 43COA194, 43DOA040, 43DPA213, 43EOA046, 43EPA048, 43FOA114, 43GOA036, 43GPA222R, 43INA035, 43INA039, 43IOA044, 43JOA021, 43KNA058, 43KQA034, 43LOA031, 43LQA036, HURB2537, HURD0674, HURF0498, and HURI0525;

j) 43APA039, 43DOA041, 43DOA202, 43DPA214, 43EOA047, 43EPA0049, 43FOA115, 43GPA209R, 43HPA055, 43HPA224R, 43INA040, 43IOA182, 43IPA047, 43JOA022, 43JPA042, 43KNA059, 43KOA021, 43KQA035, 43LOA032, 43LQA037, HURA1325, HURH0261, HURJ0606, and HURJ1589;

k) 43APA040, 43BPA028, 43DPA049, 43EPA050, 43EPA228, 43EQA055, 43FOA116, 43FQA041, 43GOA037, 43GPA211R, 43HOA036, 43HPA218, 43HPA226R, 43HQA032, 43INA041, 43I0A045, 43K0A022, 43KQA036, 43LOA033, 43LQA038, HURA1329, HURG1455, HURH1092, HURJ0607, and HURJ1590;

l) 43APA041, 43BQA048 43bQA187, 43DOA201, 43DPA050, 43DPA215, 43DQA067, 43EOA048, 43FOA117, 43FPA178, 43FQA042, 43GPA151, 43GPA212R, 43GPA236R, 43GQA035, 43HOA037, 43HPA056, 43HQA033, 43IOA046, 43IPA048, 43IQA032, 43JNA049, 43JNA222, 43JOA023, 43JPA043, 43KPA058, 43KQA037, 43LNA057, 43LOA034, HURD0675, HURD1929, HURE2907, HURF0500, HURH1093, HURJ0608, HURJ1591, and HURK1515;

m) 43APA042, 43COA041, 43DOA042, 43DOA200, 43DPA051, 43DQA068, 43EOA049, 43EPA052, 43FOA118, 43FPA179, 43FQA043, 43GOA038, 43GPA152, 43GPA213R, 43GPA238R, 43GQA036, 43HOA038, 43HPA057, 43HPA227R, 43HQA034, 43IOA047, 43IPA049, 43IQA033, 43JNA050, 43JNA223, 43JOA024, 43JPA044, 43KOA023, 43KOA161, 43KQA038, 43LNA058, 43LOA035, 43LQA040, HURA1337, HURB2433, HURE2908, HURF0501, HURH1094, HURJ0609, HURJ1592, and HURL0235;

n) 43AOA045, 43BOA041, 43BPA031, 43BQA049, 43BQA188, 43DOA043, 43DPA052, 43DPA216, 43EOA050, 43EPA053, 43FOA119, 43GPA214R, 43HPA058, 43HPA228R, 43HQA035, 43INA044, 43IOA048, 43IPA050, 43JOA025, 43JPA045, 43KOA024, 43KPA059, 43KQA039, 43LOA036, 43LPA041, 43LQA041, HURA1339, HURC9895, HURG1456, HURH1095, HURJ0610, and HURJ1593;

o) 43AOA025, 43BOA024, 43BOA042, 43BQA009, 43BQA050, 43COA021, 43COA042, 43CQA026, 43DOA023, 43DPA024, 43DPA217, 43DQA019, 43DQA069, 43EOA025, 43EPA022, 43EQA019, 43FOA091, 43FOA120, 43FPA180, 43FQA008, 43GOA019, 43GOA039, 43GPA153, 43GPA176R, 43GPA191R, 43GPA215R, 43GPA216R, 43GPA217R, 43GPA239R, 43GQA012, 43HOA040, 43HPA028, 43HPA059, 43HPA219, 43INA018, 43INA045, 43IOA049, 43IPA026, 43IPA051, 43IPA205R, 43IQA015, 43JOA026, 43JPA022, 43JPA046, 43JQA008, 43KNA019, 43KNA061, 43KOA025, 43KPA020, 43KQA008, 43LNA028, 43LNA059, 43LOA037, 43LPA011, 43LQA009, HURB2435, HURD0683, HURD1931, HURE2909, HURH1096, HURJ0612, HURJ1595, HURK1516, HURA1341, HURD1930, HURG1457, HURI0867, and HURJ0611;

p) 43AOA026, 43AOA046, 43ARA010, 43ARA286, 43ARA288, 43BOA025, 43BOA043, 43BPA014, 43BPA032, 43BQA051, 43BQA189, 43COA022, 43COA195, 43CQA233, 43DOA024, 43DOA044, 43DPA025, 43DPA218, 43DPA219, 43DQA020, 43DQA070, 43EPA023, 43EPA055, 43EPA213, 43EQA020, 43FOA092, 43FOA121, 43FOA228, 43FQA009, 43GOA020, 43GOA040, 43GPA154, 43GPA181R, 43GPA182R, 43GPA193R, 43GPA194R, 43GPA241R, 43GQA013, 43HOA019, 43HOA041, 43HPA029, 43HQA010, 43INA046, 43IOA050, 43IPA027, 43IPA052, 43IQA010, 43IQA034, 43JNA207, 43JOA027, 43JPA023, 43JPA047, 43JQA009, 43KNA020, 43KNA062, 43KPA021, 43KPA060, 43KQA040, 43LNA029, 43LOA038, 43LPA012, 43LPA013, 43LPA042, 43LPA111, 43LQA010, 43LQA042, HURA1342, HURD0697, HURD1932, HURE2910, HURF0503, HURG1246, HURG1459, HURH1097, HURI0680, HURJ1596, HURK1517, HURD0689, HURD1933, HURE3341, HURG1460, HURH1098, HURJ0613, and HURJ1597;

q) 43AOA027, 43APA043, 43ARA011, 43ARA043, 43ARA289, 43BOA026, 43BPA015, 43BQA010, 43COA023, 43CPA022, 43CQA027, 43CQA237, 43DOA025, 43DOA045, 43DPA026, 43DPA220, 43DPA221, 43DQA021, 43DQA071, 43EPA056, 43EPA241, 43EQA021, 43EQA056, 43EQA207, 43FOA093, 43FOA122, 43FOA235, 43FQA010, 43GOA021, 43GOA041, 43GPA155, 43GPA156, 43GPA183R, 43GPA218R, 43GPA219R, 43GPA242R, 43GQA014, 43HPA030, 43HPA060, 43HPA237, 43HQA011, 43INA9020, 43INA047, 43IOA023, 43IPA028, 43IPA053, 43IQA011, 43JNA208, 43JOA028, 43JPA024, 43JPA048, 43JPA203, 43JQA010, 43 JQA031, 43KOA026, 43KPA022, 43KQA010, 43KQA041, 43LNA030, 43LNA060, 43LOA039, 43LQA011, HURA1343, HURD1934, HURE2214, HURE2911, HURF0505, HURG1461, HURH1099, HURI0682, HURJ1599, HURK1291, HURA1344, HURCA110, HURE3342, HURF0506, HURH0272, HURH1100, HURJ0614, and HURL0236;

r) 43LQA012, 43LPA015, 43LOA040, 43LOA011, 43KQA042, 43KQA011, 43KPA023, 43KOA027, 43KNA064, 43KNA022, 43JQA032, 43JQA011, 43JPA025, 43JOA029, 43JNA019, 43JNA007, 43IQA012, 43IPA029, 43IOA052, 43IOA024, 43lNA048, 43HQA012, 43HPA031, 43GQA015, 43GPA243R, 43GPA203R, 43GPA202R, 43GPA201R, 43FOA094, 43EQA057, 43EQA022, 43EPA057, 43EPA025, 43EOA028, 43DQA022, 43DPA224, 43DPA223, 43DOA046, 43CQA028, 43COA024, 43BQA190, 43BQA052, 43BQA011, 43BOA176, 43APA016, HURA1345, HURB3430, HURD1935, HURE2912, HURF0507, HURG1462, HURH1101, HURJ0008, HURJ1600, HURK1518, HURB2543, HURE3343, and HURJ0615;

s) 43APA017, 43APA044, 43DPA027, 43EPA026, 43EPA058, 43EPA221, 43EQA058, 43FOA124, 43GPA157, 43GPA223R, 43GPA245R, 43HPA032, 43HPA061, 43IPA054R, 43JNA051, 43JOA030, 43JPA049, 43KNA065, 43KOA028, 43KQA043, 43LQA045, HURA1346, HURD0570, HURE2915, HURH0005, HURB2443, HURB2546, HURD0569, HURE0371, and HURJ0894;

t) 43APA018, 43BPA033, 43BQA053, 43CPA025, 43DPA028, 43DPA053, 43FPA181, 43GPA158, 43GPA159, 43HPA062, 43HPA233R, 43HQA036, 43INA049, 43IOA053, 43JNA052, 43JOA031, 43JPA050, 43KNA066, 43KOA029, 43KPA061, 43KQA044, 43LOA041, 43LPA043, 43LQA046, HURA1348,HURE3351, HURF0511, and HURJ0895;

u) 43APA019, 43APA045, 43BPA193, 43BQA054, 43BQA191, 43COA043, 43CPA026, 43CPA027, 43DOA047, 43EPA028, 43EPA060, 43FOA125, 43FQA044, 43GOA042, 43GPA160, 43GPA161, 43GQA037, 43HPA063, 43HQA037, 43IOA183, 43IQA035, 43IQA175, 43JNA053, 43JOA032, 43JPA051, 43KNA067, 43KOA030, 43KQA045, 43LNA062, 43LOA042, 43LQA047, HURH0006, HURI0364, HURJ0259, HURJ1608, HURK1519, HURB2547, HURE2916, HURG1467, HURH0714, HURJ0896, HURJ1607, HURJ1609, and HURK1520;

v) 43APA020, 43APA046, 43APA193, 43BPA188, 43BQA055, 43CPA028, 43CPA029, 43DPA030, 43EOA193, 43EPA029, 43EPA223, 43FOA126, 43FPA182, 43GPA162, 43GPA163, 43GQA175, 43HPA064, 43INA051, 43IQA036, 43JOA033, 43JPA052, 43JQA033, 43KOA031, 43KPA062, 43KQA046, 43LNA063, 43LOA043, 43LPA044, 43LQA048, HURE2918, HURF0513, HURG1468, HURH1498, HURI0681, HURJ0898, HURA1350, HURCA120HURE2917, HURF0176HURH1109, HURJ0899, and HURK1521

w) 43AOA047, 43APA021, 43BPA206, 43COA044, 43CPA030, 43DPA031, 43FOA127, 43GPA183, 43GPA164, 43GPA165, 43GPA207R, 43GPA208R, 43HPA038, 43HPA065, 43HPA229R, 43IOA184, 43JOA034, 43KNA069, 43KOA032, 43LNA064, 43LQA049, HURE2919, HURG1469, HURH1110, HURJ0900, and HURK1522
RECALLING FIRM/MANUFACTURER
Recalling Firm: C R Bard Inc., Salt Lake City , UT , by letter on September 23, 2008.
Manufacturer: Bard Puerto Rico, Humacao, Puerto Rico . Firm initiated recall is ongoing.
REASON
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
VOLUME OF PRODUCT IN COMMERCE
21,079 units
DISTRIBUTION
Nationwide, Latin America, Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany
___________________________________
PRODUCT
Modular Shoulder Body Assembly, 15mm, Left (SH-1540L-S) and Modular Shoulder Body Assembly, 15mm, Right (SH-1540R-S). Product labeled in part, Recall # Z-0447-2009
CODE
Lot : W51097 (W=work order, ###=sequential number); Expiration date: 2012-06 (Year/Month); Modular Shoulder Body Assembly, 15mm, Right : Part number: SH-1540R-S ; Work order number/Lot: W51098 (W=work order, ###=sequential number); Expiration date: 2012-06 (Year/Month).
RECALLING FIRM/MANUFACTURER
Acumed LLC, Hillsboro , OR , by letter on May 13, 2008. Firm initiated recall is ongoing.
REASON
The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide, UK , South Korea , South Africa , and Spain
___________________________________
PRODUCT
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity" PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity" PACS infrastructure, Recall # Z-0460-2009
CODE
1) Software version 2.1.X (from 2.1.2.1 to 2.1.5.4 inclusive for the patient jacket issue and all 2.1.x releases prior to 2.1.5.1 for the default display protocol issue), and 2) Software version 3.0.X (from 3.0.0.0 to 3.0.3.1 inclusive for the patient jacket issue and all 3.0.x releases prior to 3.0.2 for the default display protocol issue).
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated September 25, 2008. Firm initiated recall is ongoing.
REASON
Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout images when displaying a study. If the user does not check the Study Date Time of the exam on the image title bar, then they may interpret the current exam as a historical study and vice versa.
VOLUME OF PRODUCT IN COMMERCE
546 units
DISTRIBUTION
Nationwide, Australia, Belgium, Brazil, Canada, Cayman Islands, Chile, Denmark, Ecuador, France, Germany, Hong Kong, Italy, Japan, Korea, Malaysia, Malta, Mexico, New Zealand, Singapore, Spain, Switzerland, Taiwan, United Kingdom and Venezuela
___________________________________
PRODUCT
RNAgents® Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use. Bottle Label: Phenol: Chloroform: Isoamyl Alcohol (Cat. # Z5112). Part Two of Two of Z5110. Size 100ml. For laboratory Use. A component of the RNAgents® Total RNA Isolation System. The RNAgents® Total RNA Isolation System provides a scalable method for RNA isolation from 6 grams of tissue or 6 x 10 (eighth power) cultured cells. The system reduces the level of chromosomal DNA, a major advantage when the downstream application of amplification and analysis of RNA transcripts is desired. Isolated RNA can be resuspended in any volume, making the system ideal for microarrays, Recall # Z-0483-2009
CODE
Lot Codes: 237809 and 248195
RECALLING FIRM/MANUFACTURER
Promega Corporation, Madison , WI , by email on May 29, 2008 and letter dated June 9, 2008. Firm initiated recall is ongoing.
REASON
Reports of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol, Promega product Z5112 is a mixture of phenol, chloroform and isoamyl alcohol. If phenol contacts skin, it can cause burns and poisoning. The fumes of this product are also harmful.
VOLUME OF PRODUCT IN COMMERCE
836 units
DISTRIBUTION
Nationwide, Canada , Mexico , Brasil , China , Japan , Germany , Singapore , Great Britain , Australia and France .
___________________________________
PRODUCT
Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analyses, Recall # Z-0485-2009
CODE
Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062, GA9043, GD9069, and GD9087
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark , DE , by telephone and letter dated September 29, 2008. Firm initiated recall is ongoing.
REASON
Reagent may exhibit unflagged inaccurate patient sample results.
VOLUME OF PRODUCT IN COMMERCE
12,773 cartons
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR DECEMBER 17, 2008

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