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U.S. Department of Health and Human Services

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Enforcement Report for January 7, 2009

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.

January 7, 2009
09-01

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Bupivacaine Hydrochloride and Epinephrine Injection, USP (Bupivacaine HCl 0.5% (9 mg) with Epinephrine 1:200,000), 1.8 mL carpule, Rx only, For Dental Use, NDC 0409-7600-01, Recall # D-148-2009
CODE
Lot 61-795-LL, exp. July 01, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter on December 16, 2008.
Manufacturer: Hospira Inc., Mc Pherson, KS. Firm initiated recall is ongoing.
REASON
Carpule stoppers contain some dry natural rubber that may have latex and the product is labeled as latex-free.
VOLUME OF PRODUCT IN COMMERCE
383,500 carpules
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Good Neighbor Pharmacy, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Good Neighbor Pharmacy Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor. NDC 24385-373-21, Recall # D-150-2009;

b) Longs Wellness, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Longs Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Recall # D-151-2009;

c) American Fare, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup 1 Patient Instruction Sheet 2 Bottles of American Fare Oral Saline Laxative Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Made in the USA, Recall # D-152-2009;

d) Preferred plus Pharmacy, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Preferred Plus Pharmacy Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL), Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Recall # D-153-2009;

e) The Medicine Shoppe, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Medicine Shoppe Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, NDC 49614-226-94, Recall # D-154-2009;

f) Leader, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Leader Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, NDC 37205-996-03, Recall # D-155-2008;

g) Select brand the lower price name brand, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Select Brand Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Recall # D-156-2009;

h) QC Quality Choice, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Quality Choice Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, NDC 63868-207-30 , Recall # D-157-2009;

i) Walgreens, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Walgreens Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Recall # D-158-2009;

j) Meijer, Preparation Cleansing Kit, simple procedure bowel cleansing kit, Ginger Lemon Flavored Oral Saline Laxative, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Meijer Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Recall # D-159-2009;

j) Relieve, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup,1 Patient Instruction Sheet, 2 Bottles of Relieve Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Recall # D-160-2009;

k) Premier Value, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Premier Value Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Recall # D-161-2009;

l) Drug mart, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of Discount Drug Mart Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Recall # D-162-2009;

m) CVS pharmacy, Preparation Cleansing Kit, Flavored Oral Saline Laxative, Simple Procedure Bowel Cleansing Kit, For colonoscopies or other medical procedures, Includes: 1 12 fl. oz. Mixing Cup, 1 Patient Instruction Sheet, 2 Bottles of CVS/pharmacy Phosphate Ginger Lemon Flavor 1.5 fl. oz (45-mL) and 1.0 fl. oz. (30-mL) Net contents 2.5 fl. oz. (75-mL), Ginger Lemon Flavor, Recall # D-163-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Unico Holdings, Inc., Lake Worth, FL, by letters on December 16, 2008. Firm initiated recall is ongoing.
REASON
This recall is being initiated in response to an FDA advisory issued on December 11, 2008 stating that OTC OSP products are not recommended for bowel cleansing, due to the rare risk of acute kidney injury from the use of OSP products with the dosages used for bowel cleansing. Additionally, the OTC OSP products are misbranded because the labeling on the product contains language intended for health care providers.
VOLUME OF PRODUCT IN COMMERCE
194,016 kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
MHL labeled Ibuprofen 200 mg Pain Reliever/Fever Reducer Advanced Formula Pain Medication, 100 tablet bottles, recall # D-147-2009
CODE
Lot # 337666, Exp 03/10
RECALLING FIRM/MANUFACTURER
Magno Humphries, Inc., Tigard, OR, by email and telephone on March 24, 2008. Firm initiated recall is complete.
REASON
Defective container; inner seal contained in the caps were not sealing to the bottles correctly.
VOLUME OF PRODUCT IN COMMERCE
2,500 bottles
DISTRIBUTION
FL, LA, MA, TN, TX
___________________________________
PRODUCT
Diclofenac Sodium Delayed-Release Tablets USP, 50 mg, Rx only, 60 tablets; NDC 0591-0338-60, Recall # D-149-2009
CODE
Lot #: W338C7047E
RECALLING FIRM/MANUFACTURER
Carlsbad Technology, Inc., Carlsbad, CA, by telephone on July 31, 2008 and letter dated September 5, 2008. Firm initiated recall is complete.
REASON
Mislabeled; bottles labeled to contain 60 tablets actually contain 100 tablets.
VOLUME OF PRODUCT IN COMMERCE
1,639 bottles
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0299-09;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0300-09;
c) Fresh Frozen Plasma, Recall # B-0301-09
CODE
a) Units: 170795192, 170795042, 170793622 (Part 1 and 2), 170792733, 170789051, 170790984, 176531970, 176533855;
b) Units: 170792733 (Part 1 and 2);
c) Units: 170790984, 176531970
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Mcallen, TX, by fax on November 15, 2007 and by telephone on November 15, November 16, November 20, 2007, July 30, 2008 and August 6, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0302-09;
b) Fresh Frozen Plasma, Recall # B-0303-09
CODE
a) and b) Unit: KT60602
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by faxed letters on October l, 2007 and February 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD, VA
___________________________________
PRODUCT
a) Medtronic MEGELLAN Autologous Platelet Separator Disposables Kit, REF Catalog Number 9320100, MDK300, MDK30066. Sterile. Model 9320100, MDK300, MDK30066, COS310 (MDK300). The Medtronic Magellan Autologous Platelet Separator Disposables Kit consists of sterile fluid pathway single-patient-use components necessary for each platelet separation procedure with the Magellan Autologous Platelet Separator Instrument, Recall # B-0320-09;

b) Medtronic Magellan Basic Platelet Separator kit, Catalog Number MDK305, MDK30566 sterile, Model MDK305, MDK30566, BOS350 (MDK305), Recall # B-0321-09;

c) Arteriocyte Medical Systems MAGELLAN® Autologus Platelet Separator Disposables Kit, Catalog Number AMS300 Sterile, Model AMS300ID, Recall # B-0322-09;

d) Arteriocyte Medical Systems MAGELLAN Basic Platelet Separator Kit, Catalog Number AMS305, AMS301 sterile, Model AMS305ID, BOS360, BOS370, COS320, COS330, Recall # B-0323-09
CODE
a) Lot # 6330342 6725441 6799124 6826348 6826356 6932845 7013496 7013517 7075241 7075259 7123759 7189715 7259411 7259429 506004274 506006002; Lot # 2955994 3047488 3122644 3242494 3453582 3843151 3919549 3972059 3972251 3972340 4053812 4109118 4164344 4196768 4847532 4847541 4913675 4913683 4913691 4979771 4979797 5032693 5090893 5090914 5090949 5245488 5245496 5528091 5535400 5535418 5625991 5626011 5626029 6019423 6109672 6134940 6134966 6200185 6258820 6258862 6258889 6405367 6405404 6405501 6444489 6517035 6589522 6666701 6666735 6725432 6792352 6792379 6826364 7013509 7123724 7123732 505000841 505002283 505002284 505003953 505005447 505006910 506001662 506003184 506004729 506006000 507000675 507002534; Lot # 9285049 9796818 9796851 9816840 9816843 9816845 9851563 9853140 9860205 9331771 7193706 7311469 7311485 7434258 7434371 7446380 7446398 7539666 7539674 7599319 7599343 7721960 7721978 7740714 7740722 7740731 7856717 7871562 7886781 7886799 7886801 9260351 9377681 9377701 9412052 9682538 9704119 9704135 9742300 9796771 9796797 9796826 9796834 9806150 9806999 9807498 9808044 9808158 9808321 9816837 9826714 9830191 9830194 9830198 9830201 9837280 9837282 9837284 9837286 9837288 9853127 9860207 9860208 9860216 9868038 9979216; Lot # 579154 586641 613879 634164 662962 759324 774619 80052696 80054317 80056919 80063536 80064479 80064978 80065803 80065958 80066436 80066935 80067611 80068447 80069230 80069876 80070642 80070826 80071390 80072061 80072112;

b) Lot # 3306056 3726886 4053821 4078112 4078139 4799235 5032677 5163984 3047541 3122652 3228588 3242507 3726923 3726966 3919426 3919493 3972155 3972315 4109193 4799227 5032685 5163992 5218931 6015844 505000842 505000843 505002285 505003954 505006911 506001664 506003185 506004730 506006001 507000676 507002535; Lot # 9285065 9377672 9796800 9816836 9816842 9331762 5164004 5164012 5291441 5291468 5311406 5311414 5425745 5535426 5670054 5670062 5670071 5713026 5713034 5713042 5775964 5775981 5775999 6015828 6016011 6019440 6093332 6200134 6200151 6200169 7075216 7123741 7189336 7189387 7311493 7311506 7708271 7708280 7740749 7856709 7871554 9102290 9242031 9331818 9377699 9405979 9682546 9682562 9704127 9704143 9704151 9796789 9796842 9796877 9808322 9815824 9816834 9816835 9816838 9816844 9830193 9830195 9830199 9830202 9837281 9837283 9837285 9837287 9868043 9949021 9951553 9979215; Lot # 588798 613000 656529 691316 701013 713511 739543 743342 80052330 80052667 80060346 80061248 80068105 80069489 80069627 80070004 80070144 80071229;

c) Lot # 9955827 9983369 9991227;

d) Lot # 9951547 9955831 9983372; Lot # 80069668; Lot # 629430 15349921 15405231; Lot # 597114 665618 80052558 80053141 80067369; Lot # 611963 701885 733424 80069624
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Cardiovascular Revascularization and Surgical Therap, Brooklyn Park, MN, by letters dated August 18, 2008.
Manufacturer: Medtronic Mexico, S. De R. L. De C. V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
Luer-Lok syringes, which lack assurance of sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
77,920 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Platelets Pheresis Irradiated, Recall # B-0326-09;
b) Platelets Pheresis, Recall # B-0327-09
CODE
a) and b) Unit: 9935527
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on October 19, 2007 and letter dated April 1, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Administration Components for I.V. Infusion packaged with Mononine (Coagulation Factor IX, Human); The Administration Components for I.V. Infusion pack, labeled sterile, contains 1 winged infusion set of I.V. infusion, one 5 micron filter spike and 1 transfer needle, REF 7C5009; The Mononine, NDC 0053-7668-04, Recall # B-0329-09
CODE
Lot 60970417; packaged with Mononine lots J22306, J22506, J22607, J22707 and J23208
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Behring L.L.C., Bradley, IL, by letters dated November 20, 2008.
Manufacturer: B. Braun Medical, Inc., Allentown, PA. Firm initiated recall is ongoing.
REASON
Sterile component packs contained in the Mononine cartons; which may have an incomplete seal between the soft blister pack and the package cover compromising the sterility of the components, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2,289 packs
DISTRIBUTION
AZ, CA, FL, GA, ID, IL, IN, IA, KS, KY, MA, MI, MO, NJ, NC, ND, PA, TN, TX, WA
___________________________________
PRODUCT
Platelets, Recall # B-0344-09
CODE
Unit: 4304995
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 8, 2008 and by follow-up letter on May 12, 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
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0345-09
CODE
Unit: 4025834
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on April 15, 2008 and by follow-up letter on April 21, 2008. 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
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0346-09
CODE
Units: 50KW04277 (2 units)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, OH, by telephone on August 11, 2007 and follow-up letter dated August 14, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0347-09
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0348-09
CODE
a) Units: 9043160 (2 units);
b) Unit: 7932252
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on April 21, 2008 and by follow-up letter dated May 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
3 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets, Recall # B-0349-09
CODE
Unit: 4246417
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 8, 2008 and by follow-up letter dated May 21, 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
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0356-09
CODE
Unit: 9085301
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on April 22, 2008 and by letter dated April 30, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Cornea, Recall # B-0359-09
CODE
Units: 04830801, 04830802
RECALLING FIRM/MANUFACTURER
Northeast PA Lions Eye Bank, Inc., Allentown, PA, by letter dated August 26, 2008. Firm initiated recall is complete.
REASON
Human tissue for transplantation, collected from a donor whose blood sample for testing, was hemodiluted, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
PA
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0360-09;
b) Platelets, Recall # B-0361-09
CODE
a) and b) Unit: 3886360
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by telephone on February 9, 2006 and by follow-up letter dated March 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0367-09
CODE
Unit: 71X265425
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on June 2, 2005. 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-0368-09
CODE
Unit: 2202646
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by electronic mail on July 16, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0369-09
CODE
Units: 7714166 Part 1; 7714166 Part 2 ;7714029 Part 1; 7714029 Part 2
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by electronic mail on June 4, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0370-09
CODE
Unit: 71X441751
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Brooksville, FL, by facsimile on September 12, 2006. 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
Platelets Pheresis Leukocytes Reduced, Recall # B-0372-09
CODE
Unit: 72H264050
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on June 27, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Brooksville, FL. 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
Platelets Pheresis Leukocytes Reduced, Recall # B-0374-09
CODE
Unit: 72 E67639X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on December 13, 2007. 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
Source Plasma, Recall # B-0376-09
CODE
Units: 363014503 and 363009807
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Fort Worth, TX, by facsimile on September 14, 2006. Firm initiated recall is complete. 
REASON
Blood products, which were collected from a donor who was deferred due to risk factors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0357-09
CODE
Unit: 9844028
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA, by telephone on May 15, 2008. 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
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Washed, Recall # B-0358-09
CODE
Unit: 40LZ21000
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria, IL, by facsimile on August 26, 2008. Firm initiated recall is complete.
REASON
Blood product, which was washed with an incorrect saline solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
GE Centricity Ultra Laboratory System Software for recording, reporting and distribution of lab results, Recall # Z-0472-2009
CODE
Software versions 3.3.2.27_P4 and 4.0.1_SP.x
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated September 19, 2008.
Manufacturer: Triple G Systems Group, Inc., Markham, Canada. Firm initiated recall is ongoing.
REASON
Software computer error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Siemens KinetDx 4.2 Workplace, 10090235. Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information, Recall # Z-0543-2009;

b) Siemens syngo Dynamics Workplace, version 5.0. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation, Recall # Z-0544-2009;

c) Siemens syngo Dynamics Workplace, version 6.0. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation, Recall # Z-0545-2009
CODE
All units
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by letter dated July 23, 2008. Firm initiated recall is ongoing.
REASON
If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
VOLUME OF PRODUCT IN COMMERCE
306 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems, Recall # Z-0507-2009;

b) Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers: 64753-126. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems, Recall # Z-0508-2009
CODE
a) Lot #: 611884;
b) Lot #: 611881
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA, by telephone October 21, 2008. Firm initiated recall is complete.
REASON
Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular. Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral Vascular and Coronary Vascular systems and for superselective angiography of peripheral and coronary vasculature, Recall # Z-0604-2009
CODE
Lot #’s: 13358689 and 13350390
RECALLING FIRM/MANUFACTURER
Cordis Corp., Miami Lakes, FL, by letter dated June 30, 2008. Firm initiated recall is complete.
REASON
Two lots have the potential for sterile PTFE contamination within the inner lumen of the catheter.
VOLUME OF PRODUCT IN COMMERCE
27 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Stryker Leibinger New Generation/Universal Mandibular System, Mandibular Recon Plate, Straight, w. Template; REF # 55-28911. A mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction, Recall # Z-0610-2009
CODE
Lot J8100F1669
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Leibinger USA, Portage, MI, by letter dated September 2008.
Manufacturer: Stryker Leibinger Gmbh, Freiburg, Germany. Firm initiated recall is ongoing.
REASON
A template is supposed to accompany the product, but it was not included with this lot.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities. a) Model 515ADS; b) Model 515ADZ; c) Model 515AKS; and d) Model 515AKZ, Recall # Z-0617-2009
CODE
a) Serial number range A561137DS - A562049DS;
b) Serial number range A538908DZ - A538924DZ;
c) Serial number range A542879KS - A543722KS;
d) Serial number A501627KZ
RECALLING FIRM/MANUFACTURER
Sunrise Medical, Somerset, PA, by telephone beginning October 30, 2008 and by letters dated November 7, 2008. Firm initiated recall is ongoing. 
REASON
Potential for sieve beds to have been incorrectly assembled.
VOLUME OF PRODUCT IN COMMERCE
428 units
DISTRIBUTION
AL, CA, FL ,GA, IN, IL, MA, MD, MI, MS, NC, NE, NH, NM, NY, PA, SD, TN, TX, VA, WI, Canada, Columbia, Germany, Mexico, Netherlands, Singapore, and United Kingdom
___________________________________
PRODUCT
Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104. Made in USA with imported components "For the fecal management of patients with little or no bowel control and liquid or semi-liquid stool", Recall # Z-0618-2008
CODE
Lot #: 08-TM-51
RECALLING FIRM/MANUFACTURER
Recalling Firm: CovaTec, Skillman, NJ, by letters on November 18, 2008.
Manufacturer: Vesta, Inc., Franklin, WI. Firm initiated recall is ongoing.
REASON
A portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.
VOLUME OF PRODUCT IN COMMERCE
795 kits
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure, Recall # Z-0644-2009;

b) CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure, Recall # Z-0645-2009
CODE
a) Lot numbers: MS0408007, MS0508033, MS0508040, 561241, 562406, 567576, 569133, 569134, 569135, 575695, 579683, and 581317;

b) Lot numbers: MS0208019, MS0208020, MS0208027, MS0208035, MS0208036, MS0408002, MS0408008, MS1007022, MS1007026, MS1207032, MS1207033, MS1207042, MS1207043, and MS1207044
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences Research Medical, Inc., Midvale, UT, by letter on November 26, 2008.
Manufacturer: Accellent, Inc., Laconia, NH. Firm initiated recall is ongoing.
REASON
Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure.
VOLUME OF PRODUCT IN COMMERCE
2,230 units
DISTRIBUTION
Nationwide, Australia, Canada, Switzerland and UK

END OF ENFORCEMENT REPORT FOR JANUARY 7, 2009
 

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