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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.
May 3, 2006
06-18
______________________________
PRODUCT
Nature's Treat Energy Plus dietary supplement containing 23.4 mg ephedrine
group alkaloids and 79.2mg caffeine alkaloids per serving. Product is packaged
in white plastic bottles with white screw top caps consisting of 120 capsules
per bottle for oral administration. Advertised dosage is 2 capsules twice
daily. The 120ct. bottles are further packaged into cases of 24 bottles.
These cases are identified by the labeling: ''***Formula #1 Capsules***120
capsules/bottle***24 bottles/case***'', Recall # F-103-6
CODE
Lot numbers: 205108 and 205109 (only lots manufactured)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nature's Treat, Inc, Gainesville, TX, by telephone on August
17, 2005.
Manufacturer: Summa RX Laboratories, Inc, Mineral Wells, TX, firm initiated
recall is ongoing.
REASON
This product contains ephedrine alkaloids.
VOLUME OF PRODUCT IN COMMERCE
480 (120 count) bottles
DISTRIBUTION
OR
______________________________
PRODUCT
Max Ten capsules in amber or white, rigid, polypropylene bottles with screw
on lid and red, orange and yellow label, labeled in part: ''***MAX TEN***DIETARY
SUPPLEMENT*** Product contains Ma-Huang Extract (10mg naturally-occurring
ephedra alkaloids). Product comes in both 30 count and 90 count sizes. Bar
Code #6 11797 32754 8 (30 count) and #6 11797 32753 8 (90 count), Recall
# F-104-6
CODE
Lot number: 07G05 and Lot number 25K05 (only two lots manufactured).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maxlabs, Houston, TX, by letter on December 8, 2005. Firm
initiated recall is ongoing.
REASON
This product contains ephedrine alkaloids.
VOLUME OF PRODUCT IN COMMERCE
20,454 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Mt. Olive * Imported Pepperoncini * 12 fl. oz. (355 mL) * Ingredients: Imported
Peppers, Water, Salt, Vinegar, Calcium Chloride, 0.1% Sodium Benzoate (Preservative),
Polysorbate 80, Turmeric, and Sodium Bisulfate (Preservative). Product is
packed in glass jars, UPC Code: 09300 00089, Recall # F-145-6
CODE
Lot number: PG0416(x) Best if used by August 2008, PG0676(x) Best if used
by September 2008, PG0696(x), Best if used by September 2008, PG0746(x),
Best if used by September 2008, PG0806(x), Best if used by September 2008,
PG0876(x), Best if used by September 2008 (Production lots (x) indicates
time code A, B, C. or D)
RECALLING FIRM/MANUFACTURER
Mr. Olive Pickle Co., Inc., Mr. Olive, NC, by letter or email on/about April
7, 2006. Firm initiated recall is ongoing.
REASON
Product contains undeclared color, FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
9,438/12 pack cases
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Oats, various styles in poly mesh bags with tote tag 5208 and additionally
labeled Grain Millers Inc. Eugene, OR. Products include:
A) Product ID: 7015 Oat Whole, Groat Weight: 2000 lbs;
B) Product ID 7300 Organic Oat Whole, Groat Weight 2000 lbs;
C) Product ID: 7030 Oat Cut, Steel Cut Weight 2000 lbs;
D) Product ID: 7033:
Oat Cut, Steel Cut Fine Weight: 2000 lbs;
E) Product ID: 7032 Oat Cut, Steel Cut Mixed Weight 2000 lbs;
F) Product ID: 7622 Organic Oat Cut, Steel Cut Weight 2000 lbs;
G) Product ID: 7027 Oat Cut, Rolled Quick #21 Weight 1800 lbs;
H) Product ID: 7361 Oat Cut, Rolled Quick #21 -- Micro Weight: 1800 lbs;
I) Product ID: 7825 Oat Whole, Rolled Regular #5 -- CHEP Weight 2000 lbs;
J) Product ID: 7362 Oat Whole, Rolled Regular #5 -- Micro Weight 1800 lbs;
K) Product ID: 7005 Oat Whole, Rolled Regular #5 Weight 2000 lbs;
L) Product ID: 7002 Oat Whole, Rolled Thick #3 -- CHEP Weight: 2000 lbs;
M) Product ID: 7010 Oat Whole, Rolled Thick #3 Weight: 2000 lbs;
N) Product ID: 7682 Oat Whole, Rolled Thick #3 Weight: 2000 lbs.;
O) Product ID: 7826 Oat Whole, Rolled Thick #3 -- SFalls Weight: 2000 lbs.;
P) Product ID: 7716 Organic Oat Whole, Rolled Regular #5 Weight: 2000 lbs.;
Q) Product ID: 7735 Organic Oat Whole, Rolled Thick #3 Weight 2000 lbs.;
R) Product ID: 7734 Organic Oat Cut, Rolled Quick #21 Weight: 1800 lbs.;
S) Product ID: 7018 Oat, Blend Roll -- CHEP Weight 1800 lbs.;
T) Product ID: 8010 Oat Fiber, BCS20 Weight 2000 lbs.;
U) Product ID: 7036 Oat, Bran #140 Weight 2000 lbs.;
V) Product ID: 7649 Organic Oat, Bran #200 Weight: 2000 lbs.;
W) Product ID: 7039 Oat, Bran #200 Weight: 2000 lbs.;
X) Product ID: 7311 Organic Oat, Whole Flour Weight: 2000 lbs.;
Y) Product ID: 7312 Organic Oat, Whole Flour -- EU Weight: 2000 lbs,
Recall # F-146-6;
b) Wheat products in poly mesh bags with tote tag 5208 and additionally labeled
Grain Millers Inc. Eugene, OR:
A) Product ID: 7859 Wheat, Zoom Crushed Red Wheat -- CMill Weight: 1800 lbs.;
B) Product ID: 7436 Wheat, Steel Cut Soft White, Millers Blend Weight: 2000
lbs.;
C) Product ID: 7812 Organic Wheat, Medium Bran Weight: 1500 lbs.;
D) Product ID: 7253 Organic Wheat, Heavy Bran Weight: 1500 lbs,
Recall # F-147-6;
c) Barley products in poly mesh bags labeled with tote tag 5208 and additionally
labeled Grain Millers Inc. Eugene, OR:
A) Product ID: 7650 Barley, Flakes Weight: 2000 lbs.;
B) Product ID: 7351 Organic Barley, Flakes Weight: 2000 lbs,
Recall # F-148-6;
d) Rye Flakes in poly mesh bags with tote tag 5208 and additionally labeled
Grain Millers Inc. Eugene, OR Product ID: 7319 Weight: 2000 lbs,
Recall # F-149-6;
e) Mixed grains in poly mesh bag with tote tag 5208 and additionally labeled
Gardenburger 3 Grain ingredients: ''NO SOAK'' WHEAT, TRITICALE, & BARLEY
Net Wt 2,000 Lbs, Recall # F-150-6;
f) Mixed grains in poly mesh bag with tote tag 5208 and additionally labeled
Grain Millers Muesli Mix Ingredients: BARLEY FLAKE, WHEAT FLAKE &
OAT FLAKE Net Wt 2,000 Lbs, Recall # F-151-6
CODE
The firm codes their products - 1st digit = production shift; 2nd, 3rd,
4th digits = Julian date; 5th digit = last digit of the year; 6th digit =
plant code.
Lot numbers: A) 202860,
B) 201860, 202960, 201760,
C) 101860, 102060, 102160, 202160, 202560, 103060,
D) 101560, 201160,
E) 103060, 201660,
F) 100960, 102960, 202960, 201760,
G) 201860,
H) 200960, 202860,
I) 101760, 201660, 102560, 103160, 203060,
J) 103360,
K) 100960, 100760, 200660, 102060, 102360, 200560, 100560,
L) 101260, 201060, 101160, 201860, 203260, 103360, 103160, 203560, 100560,
M) 101660, 201660, 103760, 203660, 200560, 201860,
N) 102060, 202060, 103160,
O) 102360, 102560, 103360, 202560,
P) 202660, 200560, 100960, 202560,
Q) 103260, 102660,
R) 101960, 201960,
S) 101260, 201860, 202260, 203060,
T) 201760, 201860, 203160,
U) 201760, 201860, 203160,
V) 100760, 100860, 200760, 101960, 201860, 201960, 103460, 103660,
203460, 203660,
W) 102160, 202060, 202560, 102360,
X) 201060, 203060, 100960, 103160, 203760, 203360,
Y) 203060;
b) Lot numbers: A) 100860, 200760, 201460,
B) 101760, 201660,
C) 200860, 100860, 200960, 202260, 202760, 202860, 203060, 103260,
103560, 103360, 203560,
D) 101160, 100660, 101060, 201060, 201860, 100560, 102060, 102160,
101960, 102260, 201960, 200560, 102360, 202260, 202160, 201760,
202760, 103160, 203060, 203360, 200660, 203160, 203260, 103360;
c) Lot numbers: A) 101660, B) 102560;
d) Lot numbers: 101660, 203560;
e) Lot number: 303260;
f) Lot number: 300960
RECALLING FIRM/MANUFACTURER
Grain Millers, Inc, Eugene, OR, by telephone and email beginning on February
19, 2006. Firm initiated recall is ongoing.
REASON
Grain products were becoming contaminated with plastic film while they were
being discharged through the tote's chute which was lined with the poly film
.
VOLUME OF PRODUCT IN COMMERCE
1,211 totes -- 1,800 & 2,000 lb. totes
DISTRIBUTION
WA, CA, OR, ID, UT and British Columbia
______________________________
PRODUCT
Prasco Laboratories, KL153 T-Tanna DM Suspension (Antihistamine/Decongestant
Antitussive * Each 5ml (one teaspoonful) contains: Chlorpheniramine Tannate/
4.5mg, Pseudoephedrine Tannate/ 75mg, Dextromethorphan Tannate/ 25mg * Cotton
Candy Flavor * Rx Only * 16 fl.oz. (473 mL) *, NDC 66993-542-57, Recall #
D-238-6
CODE
Batches GB780, GB791, GB953, GB957
RECALLING FIRM/MANUFACTURER
Kiel Laboratories, Gainesville, GA, by letter on January 5, 2006, firm initiated
recall is ongoing.
REASON
Superpotent: Out of specification results were detected.
VOLUME OF PRODUCT IN COMMERCE
6,376 bottles
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0608-6
CODE
Unit numbers: 10291-1549 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on July 12, 2004, firm
initiated recall is complete.
REASON
Blood products, collected in an apheresis collection kit that may have exceeded
the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
______________________________
PRODUCT
Recovered Plasma, Recall # B-0894-6
CODE
Unit number: 36FF00603
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by letter
dated December 30, 1999, firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis, but was collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________
PRODUCT
Red Blood Cells, Irradiated, Recall # B-0898-6
CODE
Unit numbers: 71L17340, 71L31791, 71L02593, 71L19122
RECALLING FIRM/MANUFACTURER
Shands Hospital Blood Bank, Gainesville, FL, by facsimile on February 6,
2004, firm initiated recall is complete.
REASON
Blood products, possibly labeled with an incorrect expiration date, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0901-6;
b) Platelets, Irradiated, Recall # B-0902-6;
c) Fresh Frozen Plasma, Recall # B-0903-6
CODE
a), b) and c) Unit numbers: 03GG53725
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by letter dated
September 11, 2000, firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
______________________________
PRODUCT
Human Cornea, Recall # B-0905-6
CODE
Tissue: 060005100
RECALLING FIRM/MANUFACTURER
Oklahoma Lions Eye Bank, Oklahoma City, OK, by telephone on January 17, 2006
and by letter dated January 20, 2006, firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior
to distribution, but was subsequently found to test repeatedly reactive for
antibodies to hepatitis B core antigen (anti-HBc) by a different facility,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
OK
_____________________________
PRODUCT
Recovered Plasma, Recall # B-0906-6
CODE
Unit number: 36LF16951
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by letter
dated January 15, 2003, firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis, but was collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0907-6;
b) Recovered Plasma, Recall # B-0908-6
CODE
a) Unit numbers: GK37669, GL16655;
b) Unit numbers: GK37669, GL25220, GL16655
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA,
by facsimile or letter beginning February 3, 2004, firm initiated recall
is complete.
REASON
Blood products, collected from a donor who provided post donation information
regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA and Switzerland
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0929-6
CODE
Unit number: 12L81544
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone
and letter on May 3, 2004, firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
______________________________
PRODUCT
Red Blood Cells, Recall # B-0930-6
CODE
Unit number: B305494
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter dated November 14, 2003,
firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
______________________________
PRODUCT
Source Plasma, Recall # B-0938-6
CODE
Unit number: 46874412
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by letter dated March 29,
2001, firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to hepatitis C virus
(anti-HCV), but was collected from a donor who subsequently tested positive
for anti-HCV, was not properly quarantined and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0939-6;
b) Fresh Frozen Plasma, Recall # B-0940-6
CODE
a) Unit numbers: 0840885, 0846107, 2000682, 0857377, 0859456;
b) Unit numbers: 0855151, 0854373
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc, Greenville, SC, by telephone beginning January
19, 2005, firm initiated recall is complete.
REASON
Blood products, associated with units that were found to contain clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MA, NC and SC
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0953-6;
b) Fresh Frozen Plasma, Recall # B-0954-6
CODE
a) and b) Unit number: 36LK31608
RECALLING FIRM/MANUFACTURER
The American National Red Cross, South Carolina Region, Columbia, SC, by
telephone on June 14, 2005 and follow-up letter dated June 17, 2005, firm
initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1008-6
CODE
Unit number: 003KF16604
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by telephone and by letter
on March 2, 2004, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability
was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1009-6
CODE
Unit numbers: 108LJ33027 (2 units), and 108LJ33030 (3 units)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Columbia, SC, by telephone on March 31,
2005 and by letter dated April 7, 2005, firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
SC
______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0892-6
CODE
Unit numbers: 11340-5471 (2 units), 11341-5953 (2 units), 11342-4559 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, El Paso, TX, by letter dated
April 28, 2005, firm initiated recall is complete.
REASON
Blood products, for which documentation of an abnormal alarm during apheresis
collection was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TX
______________________________
PRODUCT
Source Plasma, Recall # B-0893-6
CODE
Unit numbers: CS041715, CS042430, CS042921, CS043871, CS046408, CS046925,
CS047544, CS048148, CS048777, CS049308, CS041876, CS042782, CS043711, CS045910,
CS046631, CS047358, CS047929, CS048534, CS049048, CS049594
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Columbia, SC, by facsimile on September 5,
2002, firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to swollen tonsils,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
NC
______________________________
PRODUCT
Red Blood Cells for manufacture of non-injectables, Recall # B-0909-6;
CODE
Unit number: GL25220
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA,
by facsimile February 3, 2004, firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided post donation information
regarding multiple high-risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0927-6;
b) Platelets Pheresis, Recall # B-0928-6
CODE
a) Unit numbers: 38C32265, 38W41246;
b) Unit numbers: 38FX01925 (split product), 38FX02036 (split product), 38FX02088,
38FX02132
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by
telephone on October 7, 2005 and follow-up letter dated October 14, 2005,
firm initiated recall is complete.
REASON
Blood products, collected from a donor at risk for leishmaniasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
IN and KY
______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0941-6
CODE
Unit numbers: 11341-8544 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, El Paso, TX, by letter dated
April 21, 2005, firm initiated recall is complete.
REASON
Blood products, for which documentation of an abnormal alarm during apheresis
collection was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0974-6
CODE
Unit number: 1029-1464
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated August 6, 2004, firm
initiated recall is complete.
REASON
Blood product, which may have been collected in an expired collection bag,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
______________________________
PRODUCT
Red Blood Cells Leukocytes
Reduced, Recall # B-1007-6
CODE
Unit number: 03GR66009
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by telephone on August 2,
2002 and by letter dated August 5, 2002, firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
______________________________
PRODUCT
a) Whole Blood, Recall # B-1010-6;
b) Red Blood Cells, Recall # B-1011-6;
c) Red Blood Cells Leukocytes Reduced, Recall # B-1012-6
CODE
a) Unit number: 12LP23592;
b) Unit numbers: Cells, units 12LP23591, 12LP23599, and 12FH85723;
c) Unit numbers: 12FX58888, 12X92241, 12X92204, 12FX58918, 12KM61344,
12KM61404, 12FX58976, 12X92248, 12LF90779, 12FV03748, 12FH85713,
12KM61339, 12KM61358, 12KM61367, 12FX58859, 12FK35068, 12M07148, and
12LF90817
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Durham, NC, by telephone on February 16,
2001 and by letter dated March 2, 2001, firm initiated recall is complete.
REASON
Blood products, which may have been stored at unacceptable temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
NC and SC
______________________________
PRODUCT
a) Baxter I-Pump Pain Management System infusion pump, product codes 2L3107,
2L3107K and 2L3107R, Recall # Z-0549-06;
b) Baxter AP II Pain Management System infusion pump, product codes 2L3105,
2L3105K, 2L3105R, 2L3105T and 2L3105W, Recall # Z-0550-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters dated
October 27, 2005.
Manufacturer: Baxter Healthcare Corp, Singapore, Singapore, firm initiated
recall is ongoing.
REASON
When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm
of the pumps may not detect the occlusion.
VOLUME OF PRODUCT IN COMMERCE
42,686 pumps
DISTRIBUTION
Nationwide, PR, Canada, Chile and China
______________________________
PRODUCT
a) Baxter I-Pump Pain Management System infusion pump, product codes 2L3107,
2L3107K and 2L3107R, Recall # Z-0551-06;
b) Baxter AP II Pain Management System infusion pump, product codes 2L3105,
2L3105K, 2L3105R, 2L3105T and 2L3105W, Recall # Z-0552-06;
c) Baxter OCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters dated
December 21, 2005.
Manufacturer: Baxter Healthcare Corp, Singapore, Singapore, firm initiated
recall is ongoing.
REASON
Delivery of unrequested PCA doses of medication due to damaged PCA cords,
partial sticking of PCA button, and fluid ingress into the pump or PCA button.
VOLUME OF PRODUCT IN COMMERCE
61,407 pumps
DISTRIBUTION
Nationwide and Internationally
_____________________________
PRODUCT
a) Liko Universal Slingbar 450 aluminum, used with the Viking M Patient Lift,
Recall # Z-0790-06;
b) Liko Universal Slingbar 450 aluminum, used with the Viking L Patient Lift,
Recall # Z-0791-06
CODE
a) Serial Numbers: 7100102 - 7100104; 7100109 7100147 - 7100159 7100179 --
7100182 7100257 - 7100261;
b) Serial Numbers: 7200202 - 7200216; 7200244 - 7200245; 7200250 - 7200257;
7200260 - 7200262
RECALLING FIRM/MANUFACTURER
Recalling Firm: Liko, Inc, Franklin, MA, by letter on January 9, 2006.
Manufacturer: Liko AB, Lulea, Sweden, firm initiated recall is ongoing.
REASON
The swivel adapter which is mounted directly above the slingbar's split center
bolt could be removed and allow the slingbar to be improperly mounted directly
into the aluminum link arm. This could cause an unsafe transfer. Patient
may fall.
VOLUME OF PRODUCT IN COMMERCE
54 lifts
DISTRIBUTION
IL, MA, MO, PA and TN
______________________________
PRODUCT
Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended
for use in fracture repair and reconstructive procedures of the craniofacial
skeleton, Recall # Z-0792-06
CODE
Product, Catalog #, Lot #, Expiration Date 1.5MM resorbable cortex screw
3MM-sterile, 800.603.10S, 1373642, 07/2009; 1.5MM resorbable cortex screw
3MM-sterile, 800.603.20S, 1372400, 07/2009; 1.5MM resorbable cortex screw
4MM-sterile, 800.604.02S, 1384887, 08/2009; 1.5MM resorbable cortex screw
4MM-sterile, 800.604.02S, 1393224, 09/2009; 1.5MM resorbable cortex screw
4MM-sterile, 800.604.04S, 2162367, 10/2009; 1.5MM resorbable cortex screw
4MM-sterile, 800.604.04S, 2175547, 01/2010; 1.5MM resorbable cortex screw
4MM-sterile, 800.604.04S, 2183488, 02/2010; 1.5MM resorbable cortex screw
4MM-sterile, 800.604.10S, 1371226, 07/2009; 1.5MM resorbable cortex screw
4MM-sterile, 800.604.20S, 1371227, 07/2009; 1.5MM resorbable cortex screw
5MM-sterile, 800.605.10S, 1372687, 07/2009; 1.5MM resorbable cortex screw
6MM-sterile, 800.606.10S, 1373640, 07/2009; 1.5MM resorbable tack 4MM-sterile,
800.614.04S, 1384577, 08/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S,
1387942, 09/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.10S, 1373751,
07/2009; 2.0MM resorbable cortex screw 4MM-sterile, 801.004.10S, 1374122,
07/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2162368,
10/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2184323,
02/2010; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.10S, 1374135,
07/2009; 2.5MM resorbable emergency screw 8MM-sterile, 801.048.02S, 1384578,
8/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1384602,
08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1393219,
09/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1372401,
07/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1376216,
08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1377498,
08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.20S, 1372402,
07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2169297,
12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2180984,
02/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384597,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384598,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384599,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392087,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392088,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1393230,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2162401,
10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163458,
10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163459,
10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2164282,
10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2167890,
10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2169299,
12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175554,
01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175801,
01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370038,
07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370040,
07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370041,
07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375932,
07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375933,
07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1376307,
07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377501,
07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377502,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1380682,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385761,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385763,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385764,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385780,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1388207,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1390841,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1392090,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393233,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393234,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1370039,
07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1376219,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1377503,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1378428,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1383881,
08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1390843,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1392089,
09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2167288,
11/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2181842,
02/2010; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1384604,
08/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1392091,
09/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 2167289,
11/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 1374134,
07/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 2175551,
01/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 1393239,
09/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 2181849,
02/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.04S, 2164288,
10/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 1373641,
07/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 2167291,
11/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.02S, 2171103,
12/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.04S, 2175552,
01/2010; 1.5MM rapid resorbable tack 4MM-sterile, 805.614.04S, 1387950, 09/2009;
1.5MM rapid resorbable tack 4MM-sterile, 805.614.10S, 2165696, 11/2009; 2.0MM
rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160255, 09/2009;
2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160256, 09/2009;
2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1374125, 07/2009;
2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1377504, 08/2009;
2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.02S, 2167290, 11/2009;
2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1384596, 08/2009;
2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388815, 09/2009;
2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1385773, 08/2009;
2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388795, 09/2009;
2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.10S, 1374136, 07/2009;
2.5MM rapid resorbable emergency screw 4MM-sterile, 806.044.02S, 1392093,
09/2009; 2.5MM rapid resorbable emergency screw 6MM-sterile, 806.046.02S,
2163371, 10/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Synthes USA, West Chester, PA, by telephone March 31, 2006
through April 3, 2006 and by letter on April 3, 2006.
Manufacturer: Synthes GmbH, Switzerland, firm initiated recall is ongoing.
REASON
Integrity of outer mylar pouch could be compromised, possibly rendering the
exterior of the inner foil pouch unsterile.
VOLUME OF PRODUCT IN COMMERCE
3,511 systems
DISTRIBUTION
Nationwide and Canada
______________________________
PRODUCT
a) Somatom CT System Emotion 16, model number 7734713. Computed tomography
x-ray system,
Recall # Z-0793-06;
b) Somatom CT System Emotion 16, model number 7393114. Computed tomography
x-ray system,
Recall # Z-0794-06;
c) Somatom CT System Sensation 40, model number 8874427 and Sensation 64,
model number 8377520. Computed tomography x-ray system,
Recall # Z-0795-06;
d) Somatom CT System Sensation Open, model number 8872017. Computed tomography
x-ray system,
Recall # Z-0796-06;
CODE
a) Serial numbers: 39049, 39050, 39012, 39015 and 39077;
b) Serial numbers: 50693, 51600, 51570, 50882 and 51573;
c) Serial numbers 57021, 57028, 57015, 57037, 57001, 57038, 57019 and
Serial numbers 54219, 54508, 54060, 54436, 54482, 54437, 54188, 54407,
54154, 54051, 54422, 54530, 54528, 54056, 54445, 54480, 54489, 54556,
54560, 54418, 54463, 54016, 54534, 54404, 54064, 54488, 54269, 54416,
54529, 54305 and 54210;
d) Serial numbers: 49208, 49311, 49207,49307 and 49330
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter
on March 9, 2006.
Manufacturer: Seimens Medical Solutions, Forchheim, Germany, firm initiated
recall is ongoing.
REASON
When using the LungCare feature in the SOMATOM CT Systems some marks made
on CT images may not be saved.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Somatom Sensation CT Systems, Sensation 10, model number 7543015,
Sensation 16, model number 7393114, Sensation 64, model number 8377520, and
Sensation Open model number 8872017, Recall # Z-0797-06
CODE
Software versions CT2006A and CT2006G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter
on March 28, 2006.
Siemens Medical Solutions, Forchheim, Germany, firm initiated recall is ongoing.
REASON
Firm became aware of a potential problem that could affect scan results and
require patient exam to be repeated when using the customized ECG-gated scan
protocols in the CT2006A and CT2006G software of their SOMAtOM Sensation
CT Systems.
VOLUME OF PRODUCT IN COMMERCE
86 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product
Number: 7209399, Recall #0798-06
CODE
Lot numbers: 50141993, 50145519, 50146091, 50146096, 50146362, 50148283,
50146365, 50153066, and 50150381
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Andover, MA, by letter dated March 24,
2006.
Manufacturer: Smith & Nephew, Inc, Endoscopy Division, Mansfield, MA,
firm initiated recall is ongoing.
REASON
The implant consists of a T1 and T2 anchor which are joined together by a
suture. The T2 portion of the implant may not advance into the deployment
position preventing deployment of the T2 anchor.
VOLUME OF PRODUCT IN COMMERCE
1,800 units
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate
to the
sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Venous
Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray.
REF 21-4653-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque
PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand
cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle,
20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer
Needle, 6 Fr Introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling
Tool,
20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices,
Product Information. EtO Sterilized. Single Use, Re-order number 21-4653-24,
Recall # Z-0800-06;
b) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate
to
the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free,
Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. tray.
REF 21-4655-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque
PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand
cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 16G Blunt Needle,
20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer
Needle, 8.5 Fr Introducer, ''J'' Guidewire, Syringes, Vein Pick, Tunneling
Tool,
20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices,
Product Information. EtO Sterilized. Single Use. Re-order Number 21-4655-24,
Recall # Z-0801-06;
c) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate
to
the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2
Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter,
1.9mm O.D. tray. REF 21-4672-24. Contents: Portal with ULTRA-LOCK
Connector, Radiopaque PolyFlow Polyurethane Catheter 5.8Fr with
CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G
PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, Point-Lok Sharps
Safety Device, Product Information. EtO Sterilized. Single Use.
Re-order Number 21-4672-24, Recall # Z-0802-06;
d) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate
to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT
T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter,
1.9mm O.D. tray. REF 21-4673-24. Contents: Portal with ULTRA-LOCK
Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER
Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH
needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle,
18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires,
2 Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle,
3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized.
Single Use. Re-order number 21-4673-24, Recall # Z-0803-06;
e) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate
to
the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free,
Low
Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D.
tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector,
Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor
Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle,
18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra
Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires, Syringes,
Vein
Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok
Sharps Safety Devices, Product Information. EtO Sterilized. Single Use.
Re-order number 21-4683-24, Recall # Z-0804-06;
f) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate
to
the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free,
Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm
O.D. tray. REF 21-4685-24. Contents: Portal with ULTRA-LOCK Connector,
Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire,
Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle,
16G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra
Thin Wall Introducer Needle, 8.5 Fr Introducer, 2 ''J'' Guidewires, Syringes,
Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok
Sharps Safety Devices, Product Information. EtO Sterilized. Single Use.
Re-order number 21-4685-24, Recall # Z-0805-06;
g) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate
to
the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite
Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm
O.D. tray. REF 21-4690-24. Contents: Portal with ULTRA-LOCK Connector,
Radiopaque PolyFlow Polyurethane Catheter 5.8Fr with CATH-FINDER Sensor
Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt
Needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO
Sterilized. Single Use. Re-order number 21-4690-24, Recall # Z-0806-06;
h) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate
to
the sterile tray containing and identified as PORT-A-CATH II Dual-lumen
Fluoro-Free Venous Access System, Dual Lumen Silicone Catheter, 3.4mm
O.D. tray. REF 21-8652-24. Contents: Dual-lumen Portal with WING-LOCK
Connector, Radiopaque Dual-lumen PolyFlow Polyurethane Catheter, 10.2 Fr
with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap,
20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, 2 GRIPPER PLUS
Non-Coring Safety needles 20G, 20G 90-degree PORT-A-CATH needle, 18G
Extra Thin Wall Introducer Needle, 11 Fr Introducer, ''J'' Guidewire, Syringes,
Tunneling Tool, 3 Point-Lok Sharps Safety Devices, Product Information. EtO
Sterilized. Single Use. Re-order number 21-8652-24, Recall # Z-0807-06
CODE
a) Lot numbers: M42229, M42693, M42899, M43378;
b) Lot numbers M42087, M43079;
c) Lot numbers: M41277, M42230,
d) Lot number: M41249;
e) Lot numbers: M41020, M41851, M42231, M42434, M42880, M43365;
f) Lot number M42679;
g) Lot number M41399;
h) Lot number M40376
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc, Saint Paul, MN, by letter dated March 29, 2006, firm
initiated recall is ongoing
REASON
One lot of Locator-Wand Cover sterile pouches may have an insufficient seal
and product sterility could be compromised. The Locator-Wand Cover is supplied
with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover
is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray.
VOLUME OF PRODUCT IN COMMERCE
1,048 trays
DISTRIBUTION
Nationwide and International
______________________________
PRODUCT
AXIOM Artis X-ray systems running software versions VB11K and VB22-G, AXIOM
Artis FC model number 5904433, AXIOM Artis BC model number 5904649, AXIOM
Artis MP model number 5904466, AXIOM Artis FA model number 5904441, AXIOM
Artis BA model number 5904656, AXIOM Artis TC model number 7728350, AXIOM
Artis TA model number 7007755, AXIOM Artis dFC model number 7412807, AXIOM
Artis dFC-MN model number 7727717, AXIOM Artis dBC model number 7728392,
AXIOM Artis dTC model number 7413078, AXIOM Artis dFA model number 7555373,
AXIOM Artis dBA model number 7555357, AXIOM Artis dTA model number 7008605,
AXIOM Artis dMP model number 7555365.
Recall # Z-0809-06;
CODE
Software versions VB11K and VB22-G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter
on March 10, 2006.
Manufacturer: Siemens Medical Solutions, Forchheim, Germany, firm initiated
recall is ongoing.
REASON
The recalling firm became aware of a potential problem when imaging patients
on their stomach on the AXIOM Artis X-ray Systems running software versions
VB11K and VB22G. In some instances, the orientation labels could be incorrect.
VOLUME OF PRODUCT IN COMMERCE
287 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Macan Model MC-4A Dental Electrosurgical Unit, Recall # Z-0810-06
CODE
Serial numbers 7001 to 7456
RECALLING FIRM/MANUFACTURER
Macan Engineering and Manufacturing Co, Inc, Chicago, IL, by letters dated
March 23, 2006 and April 5, 2006. Firm initiated recall is ongoing.
REASON
The product label fails to warn users to use the device on patients with
shielded pacemakers only.
VOLUME OF PRODUCT IN COMMERCE
455 units
DISTRIBUTION
Nationwide and Canada
______________________________
PRODUCT
MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and
Relief) System. The product is packaged in a tyvek pouch and is sold sterile.
The product is labeled on the tyvek pouch with a stick-on label that reads
in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot
#:**Latex Free***SINGLE USE'', Recall # Z-0811-06
CODE
All Lot codes listed as follows are affected: 30K200116, 31A160060, 31A250027,
31B280077, 31E160051,31H030002, 31I140023, 31J050052,31J250065, 32C070041,
32I050037, 32K250019, 33A300046, 33C170028, 33E290076, 33H220008, 3L170057,
34B16D038, 34B26D062, 34E05D055, 34F09D079, 34H05D023, 34H25D034, 34T17D091,34J14D021,
34L16D040
RECALLING FIRM/MANUFACTURER
Medex, Inc, Dublin, OH, by letter dated November 11, 2005, firm initiated
recall is ongoing.
REASON
The product is labeled as 'Latex Free'; however, one of the components of
the finished product may contain latex.
VOLUME OF PRODUCT IN COMMERCE
2,480 devices
DISTRIBUTION
AL
______________________________
PRODUCT
MX441B, CVP Manometer. The product is packaged in a cardboard box. The units
are packed ten (10) per case. The product is labeled on the outer case with
a stick-on label that reads in part, ''**STERILE***MX441B CVP Manometer**Lot#***Latex
Free'', Recall # Z-0812-06
CODE
All of the following lot codes are affected: Lot Numbers: 30J030048, 30K150054,
31A030144, 31b120110, 31B355998, 31C190086, 31c260053, 31D300042, 31F80073,
31I240006, 31J220068, 32C250072, 32H050182, 32K050108, 33f030089, 33G210028,
33J270026, 34C01D100, 34G01D063, 35A04D101, 35A31D040, 35C29D125
RECALLING FIRM/MANUFACTURER
Medex, Inc, Dublin, OH, by letter dated November 18, 2005, firm initiated
recall is ongoing.
REASON
The product is labeled as 'Latex Free' , however,one of the components of
the finished product may contain latex.
VOLUME OF PRODUCT IN COMMERCE
6,910 devices
DISTRIBUTION
Nationwide and Canada
______________________________
PRODUCT
a) TII0002 Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown
130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable, Recall
# Z-0813-06;
b) VariSource AL 13199023 Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm
Leader,
85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons: 20/PKG,
Recall # Z-0814-06;
c) TIT0001-003, Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader,
85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons,
Recall # Z-0815-06;
d) VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR),
10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable,
Recall # Z-0816-06;
e) KCV0008-001, AOS Intralumenal Kit: Intralumenal Implant Tubes (5EA),
Recall # Z-0817-06;
f) VariSource AL 13197000, Tongue/Soft Tissue Kit, Recall # Z-0818-06;
g) KTV0006-002, AOS Tongue And Soft Tissue Kit: AOS Tngue And Soft Tissue
Inplant Tubes (20EA); 20CM S.S. Implant Needles, 14 Degrees (20EA),
Recall # Z-0819-06;
h) VariSource AL13198000, Intralumenal Kit, Recall # Z-0820-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Alpha Omega Services, Inc, Bellflower, CA, by letters beginning February
22, 2006, firm initiated recall is ongoing/
REASON
There is a possibility that the diameter of the catheter does not meet specifications.
As a result it may not be possible to correctly connect the catheter to a
VariSource Quick Connect. This would prevent any treatment. Furthermore,
since the problem would not be apparent until after the catheter has been
implanted an unnecessary surgical implantation procedure would have taken
place.
VOLUME OF PRODUCT IN COMMERCE
1,829 devices
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
CALM software. This software is intended for use as a central monitoring
system with signal analysis and remote repeaters in the perinatal clinical
environment. It interfaces with standard fetal and maternal monitors and
provides fetal surveillance, monitoring of labor progress, charting, reporting
and data analysis, display and archiving functions, Recall # Z-0821-06
CODE
Software version 02.09.01
RECALLING FIRM/MANUFACTURER
LMS Medical Systems Ltd, Montreal, Canada, by telephone on January 11, 2005
and by email or fax on/about January 13, 2005, firm initiated recall is complete.
REASON
A deficiency in the software code can, in certain circumstances, cause data
for the wrong patient to be displayed in the Tracing Review screen when a
user is acknowledging an Alert.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
AL, IL, MD, NH, OH and Canada
______________________________
PRODUCT
Keramos Ceramic-on-Ceramic Acetabular System, Porous titanium flared rim
acetabular shell with three clustered holes in even sizes from 48 to 66mm,
a hip prosthesis component. The lot number on the product labeling is the
unique identifier of this component, Recall # Z-0799-06
CODE
Lot numbers: 276202 and 270512
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by letters on January 12, 2006 and January
30, 2006. Firm initiated recall is ongoing.
REASON
Voids in the porous coating of a component used in total hip replacement
surgery.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Royal Canin Veterinary Diet Canine Urinary SO, Food for Dogs, packaged
in 13.6 oz. cans, 24 cans per case, Recall # V-067-6;
b) Royal Canin Veterinary Diet Canine Low Fat LF, Food for Dogs, packaged
in 13.6-oz. cans, 24 cans per case, Recall # V-068-6;
c) Royal Canin Veterinary Diet Canine Calorie Control CC In Gel, Food for
Dogs,
packaged in 12.7-oz. cans, 24 cans per case, Recall # V-069-6;
d) Royal Canin Veterinary Diet Feline Sensitivity VR, Food for Cats, packaged
in 5.8-oz. cans, 24 cans per case, Recall # V-070-6;
e) Royal Canin Veterinary Diet Feline Calorie Control CC, Food for Cats,
packaged in
5.8-oz. cans, 24 cans per case, Recall # V-071-6;
f) Royal Canin Veterinary Diet Feline Renal LP, Food for Cats, packaged in
a 3.0-oz.
pouch, 24 pouches per case, Recall # V-072-6
CODE
a) Code 511A/B, Exp. 03/2007; Code 521 A/B, Exp. 03/2007;
Code 525A, Exp. 06/2007;
b) Code 526A/B, Exp. 06/2007;
c) Code 515B, Exp. 04/2007; and Code 528A, Exp. 07/2007;
d) Code 518A, Exp. 05/2007;
e) Code 449A, Exp. 11/2006; Code 451A, Exp. 12/2006, and Code 515A, Exp.
04/2007;
f) Code 519B, Exp., 09/2006; Code 522B, Exp. 09/2006; Code 526A, Exp. 10/2006,
and
Code 541A, Exp. 02/2007, and Code 543A, Exp. 02/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Royal Canin USA, Inc, Saint Charles, MO, by letters dated
February 2, 2006 and March 6, 2006.
Manufacturer: MasterFoods, USA, Vernon, CA, firm initiated recall is ongoing.
REASON
The products contain excess levels of Vitamin D3
VOLUME OF PRODUCT IN COMMERCE
31,414/24-can cases and 13,850/24-pouch cases
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Charm SL-6 Test. SL-6 Beta Lactam Assay 100 Test kits and 20 Test kits
Item Number: LF-SL6-100 and LF-SL6-20, Recall # V-073-6
CODE
Lot 021, Exp. Date: APR 2006;
Lot 022, Exp. Date: JUN 2006
RECALLING FIRM/MANUFACTURER
Charm Sciences, Inc., Malden, MA, by telephone starting on March 17, 2006.
Firm initiated recall is complete.
REASON
Tests may provide false negative results for drugs of bulk tanker milk.
VOLUME OF PRODUCT IN COMMERCE
125,000 tests
DISTRIBUTION
Nationwide and Canada
END OF ENFORCEMENT REPORT FOR MAY 3, 2006
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