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U.S. Department of Health and Human Services

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Enforcement Report for May 5, 2004

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 5, 2004
04-18

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Home Pride Butter Top Enriched White Bread packaged in
plastic bags labeled as net weight 1 lb. 4 oz.
Recall # F-187-4.
CODE
Mar 10 46057 0306, Mar 12 46059 0308, Mar 14 46061 0310, Mar 15 46062 0311.
RECALLING FIRM/MANUFACTURER
Interstate Brands Corp. Hdqtrs, Kansas City, MO, by letter on March 6, 2003. Firm initiated recall is complete.
REASON
Ingredient statement does not declare whey, nonfat dry milk, and butter.
VOLUME OF PRODUCT IN COMMERCE
9,257 loaves.
DISTRIBUTION
FL.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Doxazosin Mesylate Tablets, 1mg, 100 count bottles.
Recall # D-148-4.
CODE
Lot Number/Expiration Date: Lot 107678A (June, 2004).
RECALLING FIRM/MANUFACTURER
IVAX Pharmaceuticals, Miami, FL, by letters on April 2, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure: 18 month timepoint (stability).
VOLUME OF PRODUCT IN COMMERCE
7,008 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
a) Senokot Granules (standardized senna concentrate),
Natural Vegetable Laxative, 2 oz and 12 oz, 15mg
sennosides per teaspoon, Recall # D-138-4;
b) Senokot Tablets (standardized senna concentrate), 8.6 mg
sennosides, Natural Vegetable Laxative, 100 count
bottles. Recall # D-139-4;
c) Senokot Syrup (extract of senna concentrate), Sennosides
8.8mg, Natural Vegetable Laxative, 8 Fl oz., Alcohol-
Free Formula. Recall # D-140-4;
d) Senokot Children's Syrup, (extract of senna
concentrate), 8.8 sennosides, 2.5 Fl. Oz. Alcohol Free.
Recall # D-141-4;
e) X-Prep Bowel Evacuant Liquid, extract of senna
concentrate, 130 mg sennosides, 2.5 Fl oz.
Recall # D-142-4;
f) X-Prep Bowel Evacuant Kit-1, Extract of Senna
concentrate, 130 mg sennosides, Bisacodyl 10 mg,
Docusate sodium 50mg, 2.5 Fl oz. Contents: X-Prep Liquid
2 1/2 Fl. oz, Alcohol-Free Formula, 2 Senokot-S Tablets,
1 Rectolax suppository. Recall # D-143-4.
CODE
a) Lot GT52 exp. 2/28/2007 Lot 69G1 exp. 2/28/2004;
b) Lot DC11 exp. 5/31/2006 Lot FF51 exp. 9/30/2006;
c) Lot RB01 exp. 10/31/2004;
d) Lot PS61 exp. 8/31/2004; Lot PS71 exp. 8/31/2004;
Lot RB21 exp. 10/31/2004; Lot RM21 exp. 11/30/2004;
e) Lot KV71 exp. 3/31/2004; Lot MD12 exp. 5/31/2004;
f) Lot PM39 exp. 5/31/2004; Lot MY59 exp. 5/31/2004.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT, by letter on February 15, 2004 and February 17, 2004. FDA initiated recall is ongoing.
REASON
Superpotent: Out of specification results obtained during retesting.
VOLUME OF PRODUCT IN COMMERCE
331,885 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1099-4.
CODE
Unit 20GY11595.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone and by facsimile on February 26, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA, and MT.
_____________________________
PRODUCT
a) Cryoprecipitated AHF. Recall # B-1106-4;
b) Recovered Plasma. Recall # B-1107-4.
CODE
a) Unit number 21KC56042;
b) Unit numbers 21KC56042 and 21KG65175.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on February 21, 2003, by facsimile on February 24, 2003, and March 27, 2003, and by letters on February 25, 2003, and April 4, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA, and Switzerland.

________________________________
PRODUCT
Red Blood Cells, Deglycerolized. Recall # B-1110-4.
CODE
Unit number: 9233644.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on November 8, 2002. Firm initiated recall is complete.
REASON
Red Blood Cells, frozen using expired glycerol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-1111-4.
CODE
Unit number: 21KS14782.
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR, by letter, dated February 25, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-1112-4.
CODE
Unit number: 21KL58423.
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR, by letter, dated February 11, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Source Plasma. Recall # B-1114-4.
CODE
Unit number: 00MMIA2571.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Marquette, MI, by facsimile on June 7, 2001. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Removed. Recall # B-1121-4.
CODE
Unit number: 2515050.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by letter, dated November 7, 2001. Firm initiated recall is complete.
REASON
Blood product, with a decreased platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-1122-4.
CODE
Unit numbers: 00GMIF4892, 00GMIF5391, 01GMIA0969, 01GMIA1738, 01GMIA3448, 01GMIA5160, 01GMIA5980, 01GMIA7787.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Bio-Resources, Inc., Grand Rapids, MI, by facsimile on May 17, 2001.
Manufacturing Firm: BioLife Plasma Services L.P., Walker, MI. Firm initiated recall is complete.
REASON
Source Plasma, collected from an unreliable donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1132-4.
CODE
Unit number: 02P66850.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Plains Region, Wichita, KS, by telephone on September 16, 2003, and by letter dated September 17, 2003. Firm initiated recall is complete.
REASON
Blood product, which was in transit greater than 48 hours and was possibly exposed to unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KS.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1134-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1135-4;
c) Platelets. Recall # B-1136-4.
CODE
a) Unit number: 3074593;
b) and c) Unit number: 3072130.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter on January 9, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1137-4.
CODE
Unit number 2040353.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on September 28, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for Cytomegalovirus (CMV), but was collected from a donor who previously tested CMV positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1138-4.
CODE
Unit number 41LH49821.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by facsimile on July 28, 2002. Firm initiated recall is complete.
REASON
Blood product collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1079-4.
CODE
Units: 9418546, 9419898, 9425289, 9425314.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on January 23, 2003, and by letter on January 13, 2004. Firm initiated recall is complete.
REASON
Blood products, out of refrigeration for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-1097-4;
b) Plasma, Frozen. Recall # B-1098-4.
CODE
a) Unit numbers: 03GT56277, 03GT56278;
b) Unit number: 03GZ33045.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southern Region, Atlanta, GA, by letters, dated April 26 and 28, 2003, and May 29, 2003, and by telephone on July 18, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from a unit of Whole Blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
GA and SC.
_____________________________
PRODUCT
Recovered Plasma. Recall # B-1100-4.
CODE
Unit 20GY11595.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone and by facsimile on February 26, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA, and MT.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1101-4.
CODE
Unit number 20GR15840.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on November 11, 2002 and by letter dated November 22, 2002. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ID.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1139-4.
CODE
Unit number 41LS09682.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone and letter on November 19, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1140-4;
b) Recovered Plasma. Recall # B-1141-4.
CODE
a) and b) Unit number 41LW80352.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by letter on May 9, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL, and CA.
_____________________________
PRODUCT
a) Platelets. Recall # B-1144-4;
b) Platelets Pheresis, Leukocytes Removed.
Recall # B-1145-4;
c) Fresh Frozen Plasma. Recall # B-1146-4;
d) Red Blood Cells, For Further Manufacturing into Non-
injectables. Recall # B-1147-4.
CODE
a), c) and d) Unit number 5164237;
b) Unit number 2514483.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile on September 4, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for Hepatitis B surface antigen (HBsAg) and for the antibody to Hepatitis B core antigen (anti-HBc), but was collected from a donor that previously tested positive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Axiom Artis System. Recall # Z-0848-04.
CODE
Part numbers 5904433, 5904649, 5904466, 5904441, 5904656, and 7007755. Serial numbers 10070, 10075, 10076, 10101, 10138, 10148, 10240, 10241, 10248, 10251, 10255, 10257, 10261, 10263, 10266, 14068, 20015, 20129, 20136, 25092, 25112, 25134, 25135, 25148, 25156, 25157, 25159, 25160, 25163, 25169, 25170, 28008, 28015, 28019, 28046, 28047, 28049, 28053, 28058, 28059, 28061, 32004, 32013, 32017, and 32019.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letters dated May 28, 2003. Firm initiated recall is ongoing.
REASON
Patient images misidentified.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Prima IIITotal SENSE Torso Coil (Body Array Coil), a Magnetic Imaging Accessory. This device is a component of the Magnetom TRIO 3.OT MRI Systems. Recall # Z-0849-04.
CODE
USAI P/N: 100352, USAI S/Ns: 310 to 388 (Rev 1 and 2); Siemens P/N: 7578789, Siemens S/Ns: 1010 to 1088.
RECALLING FIRM/MANUFACTURER
USA Instruments, Inc., Aurora, OH, by letter on March 19, 2004. Firm initiated recall is ongoing.
REASON
A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's skin.
VOLUME OF PRODUCT IN COMMERCE
79 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) GE Single 15 inch TV Monitor Suspension with Rail, Model
46-240485P1, Catalog number B0256EH. Recall # Z-0850-04;
b) GE Single 15 inch TV Monitor Suspension for XT Bridge,
Model 46-240485P2, Catalog Number B2056HA. Recall # Z-
0851-04;
c) GE Single 20 inch TV Monitor Suspension with Rail, Model
46-240485P5, Catalog Number B2056EC. Recall # Z-0852-04;
d) GE Single 20 inch TV Monitor Suspension for XT Bridge,
Model 46-240485P6, Catalog Number B2056EG. Z-0853-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, Waukesha, WI, by Field modification instructions on March 30, 2004. Firm initiated recall is ongoing.
REASON
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
VOLUME OF PRODUCT IN COMMERCE
1,236 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) CryoValve Aortic Valve. Donor #71893, Model #AV00.
Recall # Z-0854-04;
b) CryoValve Conduit and Pulmonary Valve and Conduit.
Donor #71899, Model #PV00. Recall # Z-0855-04.
CODE
a) Serial # 8079912;
b) Serial # 8080113.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on March 2, 2004. Firm initiated recall is ongoing.
REASON
A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Port-A-Cath II Low Profile Epidural Implantable Access
System, with PolyFlow Polyurethane Catheter, 1.2mm O.D.
x 0.5mm I.D., REF 21-1501-01. Recall # Z-0856-04;
b) Port-A-Cath II Epidural Low Profile Polysulfone/Titanium
Access System, with PolyFlow Polyurethane Catheter,
1.2mm O.D. x 5mm I.D., REF 21-1501-22. Recall # Z-0857-
04;
c) 6 Fr Introducer Set, REF 21-2320-24. Recall # Z-0858-04;
d) 9 Fr Introducer Set, REF 21-2340-24. Recall # Z-0859-04;
e) 8.5 Fr Introducer Set, REF 21-2370-24. Recall # Z-0860-
04;
f) Port-A-Cath Titanium Venous Access System, with Silicone
Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set,
REF 21-4003-24. Recall # Z-0861-04;
g) Port-A-Cath Titanium Venous Access System, with Silicone
Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr Introducer Set,
REF 21-4009-24. Recall # Z-0862-04;
h) Port-A-Cath Low Profile Titanium Venous Access System,
with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D., 9 Fr
Introducer Set, REF 21-4035-24. Recall # Z-0863-04;
i) Port-A-Cath Low Profile Titanium Venous Access System,
with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm
I.D., 6 Fr Introducer Set, REF 21-4037-24. Recall # Z-
0864-04;
j) Port-A-Cath II Polysulfone/Titanium Venous Access
System, with Silicone Catheter, 2.8mm O.D. x 1.0mm I.D.,
9 Fr Introducer Set, REF 21-4051-24. Recall # Z-0865-04;
k) Port-A-Cath II Polysulfone/Titanium Venous Access
System, with PolyFlow Polyurethane Catheter, 2.6mm O.D.
x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4055-24.
Recall Z-0866-04;
l) Port-A-Cath II Low Profile Polysulfone/Titanium Venous
Access System, with PolyFlow Polyurethane Catheter,
2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-
4071-24. Recall Z-0867-04;
m) Port-A-Cath II Low Profile Polysulfone/Titanium Venous
Access System, Pre-assembled with PolyFlow Polyurethane
Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer
Set, REF 21-4073-24. Recall # Z-0868-04;
n) Port-A-Cath II Low Profile Polysulfone/Titanium Venous
Access System, with PolyFlow Polyurethane Catheter,
1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-
4083-24. Recall # Z-0869-04;
o) Port-A-Cath II Low Profile Polysulfone/Titanium Venous
Access System, Pre-assembled with PolyFlow Polyurethane
Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set,
REF 21-4085-24. Recall # Z-0870-04;
p) ProPort Plastic Venous Access System, with PolyFlow
Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5
French Introducer Set, REF 21-4155-24. Recall # Z-0871-
04;
q) ProPort Plastic Venous Access System, Pre-assembled wit
PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D.,
8.5 French Introducer Set, REF 21-4165-24. Recall # Z
-0872-04;
r) ProPort Low Profile Plastic Venous Access System, with
PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D.,
8.5 French Introducer Set, REF 21-4171-24. Recall # Z-
0873-04;
s) ProPort Low Profile Plastic Venous Access System, with
PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D.,
6 French Introducer Set, REF 21-4183-24. Recall # Z-
0874-04;
t) Port-A-Cath P.A.S. Port T2 Titanium Venous Access
System, with PolyFlow Polyurethane Catheter, 1.9mm O.D.
x 1.0mm I.D., 6 French Introducer Set, REF 21-4573-24.
Recall # Z-0875-04;
u) Port-A-Cath II Fluoro-Free Low Profile Venous Access
System, with PolyFlow Polyurethane Catheter, 2.6mm O.D.
x 1.6mm I.D., and with CATH-FINDER Sensor Wire, REF 21-
4685-24. Recall # Z-0876-04;Recall # Z-0876-04;
v) Port-A-Cath II Dual-lumen Low Profile
Polysulfone/Titanium Venous Access System, with Dual-
lumen PolyFlow Polyurethane Catheter, 2.2mm O.D. x 1.0mm
I.D., 7 French Introducer Set, REF 21-8066-24. Recall #
Z-0877-04;
w) Port-A-Cath II Dual-lumen Low Profile
Polysulfone/Titanium Venous Access System, with Dual-
lumen PolyFlow Polyurethane Catheter, 3.2mm O.D. x 1.4mm
I.D., 10 French Introducer Set, REF 21-8068-24. Recall #
Z-0878-04.
CODE
a) Lot M27052;
b) Lot M27037;
c) Lot M26890;
d) Lot M27142;
e) Lot M27129;
f) Lot M27043;
g) Lot M27134;
h) Lot M27051;
i) Lots M27118 and M27262;
j) Lots M26978 and M27138;
k) Lots M27038, M26962, and M27119;
l) Lots M26963, M27058, and M27120;
m) Lot M27131;
n) Lots M26971 and M27045;
o) Lot M26982;
p) Lot M27054;
q) Lot M27136;
r) Lot M27046;
s) Lot M27048;
t) Lot M27049;
u) Lot M27047;
v) Lot M26975 and M27127;
w) Lot M26983;
RECALLING FIRM/MANUFACTURER
Deltec, Inc., Saint Paul, MN, by letter dated March 26, 2004. Firm initiated recall is ongoing.
REASON
Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
VOLUME OF PRODUCT IN COMMERCE
2,406 units (access ports or introducers).
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Colleague Single Channel Volumetric Infusion Pumps,
product code 2M8151 and 2M8151K (United Kingdom); Made
in Singapore; monochrome display screen. Recall # Z-
0879-04;
b) Colleague 3 Triple Channel Volumetric Infusion Pumps,
product code 2M8153 and 2M8153K (United Kingdom); Made
in Singapore; monochrome display screen. Recall # Z-
0880-04;
c) Colleague CX Single Channel Volumetric Infusion Pumps,
product code 2M8161; Made in Singapore; color display
screen. Recall # Z-0881-04;
d) Colleague 3 CX Triple Channel Volumetric Infusion Pumps,
product code 2M8163; Made in Singapore; color display
screen. Recall # Z-0882-04.
CODE
a) Product code 2M8151- serial numbers 12040343CS and
above; Product code 2M8151K - serial numbers 13010001CK
and above;
b) Product code 2M8153 - serial numbers 12110481CT and
above; product code 2M8153K - serial numbers 12120001TK
and above;
c) Product code 2M8161 - serial numbers 12020001CC and
above;
d) Product code 2M8163 - serial numbers 12030001TC and
above.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation, Round Lake, IL., by letters dated April 13, 2004. Firm initiated recall is ongoing.
REASON
Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.
VOLUME OF PRODUCT IN COMMERCE
195,216 pumps.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
LIFEPAK 500 automated external defibrillator. Part numbers
3005380-000 through 3005380-006 and 3005380-014. Recall #
Z-0886-04.
CODE
Serial numbers may be obtained from the firm or from Seattle District Recall Coordinator. All battery date codes prior to 0013.
RECALLING FIRM/MANUFACTURER
Medtronic Physio Control Corp, Redmond, WA, by telephone on April 2, 2004. Firm initiated recall is ongoing.
REASON
Potential for batteries to malfunction due to battery cell rupture.
VOLUME OF PRODUCT IN COMMERCE
7,028 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
EZ-DOP, diagnostic ultrasound imaging system. Recall # Z-
0885-04.
CODE
Serial numbers LDP4 0024 through LDP4 390.
RECALLING FIRM/MANUFACTURER
DWL Systems, Inc., Sterling, VA, by letter on January 5, 2004. Firm initiated recall is ongoing.
REASON
A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.
VOLUME OF PRODUCT IN COMMERCE
367 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
Regu-Mate (altrenogest) Oral Progestin 1,000 ml Solution 0.22%. The product is sold in one liter bottles and shipped in cases that contain 6 bottles. Recall # V-128-4.
CODE
Item # 069285, Lot numbers THAR and TIEH.
RECALLING FIRM/MANUFACTURER
Intervet, Inc., Millsboro, DE, by telephone on February 24, 2004. Firm initiated recall is complete.
REASON
Product may leak.
VOLUME OF PRODUCT IN COMMERCE
8,037 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.

END OF ENFORCEMENT REPORT FOR MAY 5, 2004

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