FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and
Drug Administration,
U.S. Public Health Service, Department of Health and Human
Services. It contains information
on actions taken in connection with agency regulatory
activities.
April 30, 1997 97-18
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Mayport Ocean Gallery Recipe Smoked Salmon
Spread, packed into 6.5 ounce plastic tubs.
Recall #F-399-7.
CODE Sell by date March 2, 1997 and February 25,
1997.
MANUFACTURER Mayport Wholesale Seafood, Inc., Green Cove
Springs, Florida.
RECALLED BY Manufacturer, by press release on January 29,
1997. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 27 cases (20 cans per case) were distributed.
REASON Product was contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT BestYet Cookies, 20 ounce size: (a) Assorted
Cookies; (b) Duplex Cookies, (c) Peanut Butter
Cookies; (d) Vanilla Sandwich Creams.
Recall #F-310/313-7.
CODE FEB 5 1997 through JUL 10 1997.
MANUFACTURER Bakeline Products, Inc., Des Plaines,
Illinois.
RECALLED BY Fleming, Inc., Oklahoma City, Oklahoma. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 538 cases; (b) 512 cases; (c) 625 cases;
(d) 669 cases were distributed.
REASON The product is misbranded due to the failure
to display required labeling in accordance
with 21 CFR 101.5
_______________
PRODUCT Triton Mountain Spring Water, in 8 ounce
bottles. Recall #F-380-7.
CODE 10-24-98-A.
MANUFACTURER Triton Water Company, Burlington, North
Carolina.
RECALLED BY Manufacturer, by telephone/letter on or about
December 9, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION New Jersey.
QUANTITY 17,280 bottles were distributed.
REASON Product is contaminated with mold.
_______________
PRODUCT Various soft drinks:
1. Coca-Cola Classic, 12 fl. ozs./cans, 20 fl.
ozs./bottles, 2 Liter/bottles
2. Caffeine-Free Coca-Cola Classic,12 fl.
ozs./cans, 2 Liter/bottles
3. Cherry Coke, 20 fl. ozs./bottles
4. Diet Coke, 12 fl. ozs./cans, 20 fl.
ozs./bottles, 2 Liter/bottles
5. Caffeine-Free Diet Coke, 12 fl. ozs./cans,
2 liter/bottles
6. Mr. Pibb, 20 fl. ozs./bottles
7. Dr. Pepper, 12 fl. ozs./cans, 20 fl.
ozs./bottles, 2 Liter/bottles
8. Diet Dr. Pepper, 12 fl. ozs./cans, 20 fl.
ozs./bottles, 2 Liter/bottles
9. Barq's Root Beer, 12 fl. ozs./cans, 20 fl.
ozs./bottles
10. Sprite, 12 fl. ozs./cans, 20 fl.
ozs./bottles, 2 Liter/bottles
11. Diet Sprite, 12 fl. ozs./cans, 2
Liter/bottles
12. Mello Yello, 12 fl. ozs./cans, 20 fl.
ozs./bottles, 2 Liter/bottles
13. Minute Maid Fruit Punch, 20 fl.
ozs./bottles
14. Minute Maid Grape, 12 fl. ozs./cans, 20
fl. ozs./bottles
15. Minute Maid Orange, 12 fl. ozs./cans, 20
fl. ozs./bottles
-2- 16. Schweppes Ginger Ale, 20 fl. ozs./bottles
17. Surge, 12 fl. ozs./cans, 20 fl.
ozs./bottles, 2 Liter/bottles.
Recall F-381/397-7.
CODE Any of the listed products with codes as
identified below:
All products in plastic non-returnable bottles
and diet soft drinks in aluminum cans with the
following codes:
MAY1297CVA; MAY1297CVB; MAY1297CVC;
MAY1297CVD; MAY1297CVE; MAY1297CVF;
MAY1297CVG; MAY1997CVA; MAY1997CVB; and
MAY1997CVC.
All regular (non-diet) soft drinks in aluminum
cans with the following codes:
NOV1097CVA; NOV1097CVB; NOV1097CVC;
NOV1097CVD; NOV1097CVE; NOV1097CVF;
NOV1097CVG; NOV1797CVA; NOV1797CVB; and
NOV1797CVC.
MANUFACTURER Johnston Coca Cola Bottling Company,
Division of Coca Cola Enterprises,
Cleveland, Tennessee.
RECALLED BY Manufacturer, by visit. Firm-initiated recall
ongoing.
DISTRIBUTION Tennessee, Alabama, Georgia.
QUANTITY Approximately 301,490 cases were distributed;
firm estimates none remains on the market.
REASON Products have an off-odor and off-flavor.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Transfilled Compressed Medical Oxygen USP
filled into E size cylinders.
Recall #D-168-7.
CODE All codes, all lots and all fill dates.
MANUFACTURER Respiratory Science Industries, Ltd., Elmont,
New York.
RECALLED BY Manufacturer, by telephone on April 11, 1997,
followed by letter on April 14, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 81 cylinders were distributed.
REASON Current good manufacturing practice
deficiencies.
_______________
PRODUCT Indomethacin Suppositories USP, 50 mg, Rx
nonsteroidal anti-inflammatory agent, under
the Qualitest, Zenith and G&W labels.
Recall #D-169-7.
CODE All lots within expiration date.
-3-MANUFACTURER G & W Laboratories, Inc., South Plainfield,
New Jersey.
RECALLED BY Manufacturer, by letter dated January 30,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 20 lots were distributed.
REASON Product lacks stability (potency assay is as
low as 58% of labeled strength).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
UPDATE Recall #D-156-7, which appeared in the April
23, 1997 Enforcement Report should have been
listed as Nycomed brand Hypaque (Diatrizoate
Sodium) Oral Solution. The powder is not
included in this recall action.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-618-7.
CODE Unit numbers: 2226275, 2226277, 2226941,
2226279, 2226942, 2226276, 1812016, 1812489,
1812001, 1812492, 1812003, 1812491, 2227887,
2226955, 1812490, 1812000.
MANUFACTURER Oklahoma Blood Institute, Oklahoma City,
Oklahoma.
RECALLED BY Manufacturer, by fax followed by letter on
January 25, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Massachusetts, Oklahoma, Texas, California.
QUANTITY 16 units were distributed.
REASON Blood products were prepared from units of
Whole Blood that were stored at room
temperature for more than 12 hours.
_______________
PRODUCT Red Blood Cells. Recall #B-619-7.
CODE Unit #5112340.
MANUFACTURER Department of the Navy, Naval Hospital,
Beaufort, South Carolina.
RECALLED BY Manufacturer, by requesting destruction of
unit on June 19, 1996. Firm-initiated recall
complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
health history screening was inadequately
performed.
-4-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-626/627-7.
CODE Unit #03GH16722.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by letter dated November 14,
1996, by telephone on November 8, 1996,
followed by letter dated November 13, 1996.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit of each component.
REASON Blood products were collected from a donor who
traveled in an area considered endemic for
malaria.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-630/633-7.
CODE Unit numbers: (a) 26F00593, 26G09071,
26G10174, 26G11575, 26G79656, 26G95204,
26L81709, 26N08544, 26FF00501
(b) 26F00593, 26G09071, 26G79656, 26G95204,
26N08544, 26FF00501
(c) 26G10174, 26G79656, 26G95204, 26N08544
(d) 26F00593, 26G09071, 26G11575, 26L81709,
26FF00501.
MANUFACTURER American Red Cross Blood Services,
Mobile, Alabama.
RECALLED BY Manufacturer, by various letters dated in
March 1995. Firm-initiated recall complete.
DISTRIBUTION Alabama, Florida, Mississippi.
QUANTITY (a) 9 units; (b) 6 units; (c) 4 units; (d) 5
units were distributed.
REASON Blood products were collected from donors with
a history of IV drug use.
_______________
PRODUCT Platelets, Pheresis. Recall #B-639-7.
CODE Unit #7346334.
MANUFACTURER Northwest Oklahoma Blood Institute, Enid,
Oklahoma.
RECALLED BY Oklahoma Blood Institute, Oklahoma City,
Oklahoma, by telephone on September 25, 1996,
followed by fax. Firm-initiated recall
complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a mixture of
anticoagulants.
-5-_______________
PRODUCT Platelets, Pheresis. Recall #B-640-7.
CODE Unit #11LF04929.
MANUFACTURER American Red Cross Blood Services, Jefferson
City, Missouri.
RECALLED BY American Red Cross Blood Services, St. Louis,
Missouri, by telephone on April 22, 1996,
followed by letter dated April 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product had saline inappropriately added
instead of plasma.
_______________
PRODUCT Red Blood Cells. Recall #B-642-7.
CODE Unit #49FM24988.
MANUFACTURER American Red Cross Blood Services, Wichita
Falls, Texas.
RECALLED BY Manufacturer, by letter dated January 27,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
was taking the drug Methotrexate.
_______________
PRODUCT Recovered Plasma. Recall #B-643-7.
CODE Unit #55C03757.
MANUFACTURER American Red Cross Blood Services, Little
Rock, Arkansas.
RECALLED BY Manufacturer, by telephone on February 12,
1997, followed by letter dated March 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Arkansas.
QUANTITY 1 unit was distributed.
REASON Blood product was not tested for viral
markers.
_______________
PRODUCT Platelets. Recall #B-645-7.
CODE Unit #49Y36552.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on December 27,
1996, followed by letter January 27, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood designated as a difficult
collection.
-6-_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-646/647-7.
CODE Unit numbers: (a) 49LF19278, 49LF25666; (b)
49LF19278, 49LF25666, 49LF13568.
MANUFACTURER American Red Cross Blood Services, Waco,
Texas.
RECALLED BY Manufacturer, by letter dated January 15, 1997
and on January 7, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas and Virginia.
QUANTITY (a) 2 units; (b) 3 units were distributed.
REASON Blood products were collected from a donor who
was taking the drug Methotrexate.
_______________
PRODUCT Platelets. Recall #B-648-7.
CODE Unit #49R76871.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letter dated February 3,
1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood designated as a difficult
collection.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-650/651-7.
CODE Unit #4003410.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone on August 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected in a manner
which could compromise the sterility of the
collection system.
_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF.
Recall #B-652/653-7.
CODE Unit #21GJ69700.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated March 14, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit of each component was distributed.
-7-REASON Blood products were collected from a donor
with a history of Hodgkin Disease.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-654/655-7.
CODE Unit #53M07743.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated October 29,
1996. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Thrombostat (Thrombin, USP-Bovine Origin).
Recall #B-528-7.
CODE Lot #00556P EXP 2/16/99.
MANUFACTURER Parke-Davis, Sterile Products Division,
Rochester, Michigan.
RECALLED BY Parke-Davis, Division of Warner-Lambert
Company, Morris Plains, New Jersey, by letter
February 27, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,915 vials were distributed.
REASON Parke-Davis improperly made fill volume
adjustments for potency of the product.
_______________
PRODUCT Baxter Gammagard & Polygam Solvent/Detergent
Treated Infusion Sets (Immune Globulin
Intravenous(Human):
(a) Baxter's Gammagard S/D 5G
(b) Baxter's Gammagard S/D 10G
(c) Baxter's Polygam S/D 5G
(d) Baxter's Polygam S/D 10G.
Recall #B-579/582-7.
CODE Lot number after 2620E061AA and after
26206056AA.
MANUFACTURER Baxter Healthcare Corporation, Glendale,
California.
RECALLED BY Manufacturer, by letter dated November 15,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
-8-QUANTITY Approximately 232,921 units were distributed.
REASON Baxter's IGIV solvent/detergent infusion sets,
have defective transfer devices which pushes
the stopper into vials of accompanying sterile
water injection producing particulate matter.
_______________
PRODUCT Platelets. Recall #B-585-7.
CODE Unit #32KJ08285.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated May 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for Bg
antibodies.
_______________
PRODUCT Platelets, Pheresis. Recall #B-586-7.
CODE Unit #29FP31456.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letters dated February 9,
1996, March 12, 1996, and April 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
was immunized with Chicken Pox vaccine.
_______________
PRODUCT Platelets, Pheresis. Recall #B-597-7.
CODE Unit numbers 11LK22485 and 11P26884.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on or about June
17, 1996, followed by letter dated June 27,
1996. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with extended
expiration dates.
_______________
PRODUCT Red Blood Cells. Recall #B-613-7.
CODE Unit #41GK78109.
MANUFACTURER American Red Cross Blood Services, Birmingham,
Alabama.
RECALLED BY Manufacturer, by telephone in September 1996,
followed by letter dated September 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Alabama.
-9-QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT Red Blood Cells. Recall #B-620-7.
CODE Unit numbers: 21GF83275 and 21GF83285.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on August 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with extended
expiration dates.
_______________
PRODUCT Red Blood Cells. Recall #B-625-7.
CODE Unit #21GF89063.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on October 14,
1996. Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT Cryopreipitated AHF. Recall #B-629-7.
CODE Unit #53FL57453.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated October 31,
1996. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood with an extended collection time.
_______________
PRODUCT Red Blood Cells. Recall #B-634-7.
CODE Unit #26FP06215.
MANUFACTURER American Red Cross, Mobile, Alabama.
RECALLED BY Manufacturer, by telephone in March 1995.
Firm-initiated recall complete.
DISTRIBUTION Alabama.
QUANTITY 1 unit was distributed.
REASON Blood product was exposed to improper storage
and unacceptable temperatures.
-10-_______________
PRODUCT Elase Ointment (Fibrinolysin &
Desoxyribonuclease Combined (Bovine)
Ointment). Recall #B-636-7.
CODE Lot #52D4 EXP 9/97.
MANUFACTURER Parke-Davis, Sterile Products Division,
Rochester, Michigan.
RECALLED BY Parke-Davis, Division of Warner-Lambert
Company, Morris Plains, New Jersey, by letter
on May 16, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 35,328 tubes were distributed.
REASON Product failed the 15 month 30 degree C
stability assay for desoxyribonuclease.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Baxter Capillary Flow Dialyzer, Model CF 15
5M1709, containing fibers from FNR 981, used
with an artificial kidney system for the
treatment of patients with renal failure or
toxemic conditions. Recall #Z-347-7.
CODE Lot H97A14169.
MANUFACTURER Baxter Healthcare Corporation, Mountain Home
Arizona.
RECALLED BY Manufacturer, by telephone on February 17,
1997. Firm-initiated recall ongoing.
DISTRIBUTION California, New Jersey, Pennsylvania, New
Mexico, Illinois, Missouri, Texas, New York.
QUANTITY 1,632 units were distributed.
REASON The blood in the dialyzer clearance values
fluctuate from the labeled values for the
dialyzer.
_______________
PRODUCT Infant Monitor, Model 500EXL, available for
hospital and home use to monitor respiration,
ECG and heart rate: (a) Catalog number:
0500FAA 120 Volts/ 60 Hz English; (b) Catalog
number: 0500FAH 230 Volts/ 50 Hz English;
Catalog number: 0500FEH 230 Volts/ 50 Hz
German. Recall #Z-419/421-7.
CODE Serial Numbers:
Cat. No.: 0500FAA:
01008736, 01110442, 01313163, 01615535,
01615537 - 01615544 - 01615546 - 01615553,
03313340 04301233, 0482335, 06414241,
07313642, 08111333, 08212735, 08301216,
0882959, 0882984, 09009743, 09009748,
09009758, 09009779, 0983171, 11313882,
11515405-11515408, 11515410 - 11515429,
-11- 11907334, 12213073, 12515449 - 12515458,
12515461, 12515462, 12515464, 12515465,
12515466, 12515468 - 12515472, 12515474 -
12515479, 12515481 - 12515487, 12515491 -
12515498, 13000022, 13000023, 13000025,
13000031, 13000034, 13000036, 13000038 -
13000040, 13000042, 13000044,
13000046-13000048, 13000050, 13000052,
13000076 - 13000115, 13000136-13000225,
13000227 - 13000241, 13000263 - 13000265,
13000321 - 13000341, 13000349 - 13000351,
99000002 - 99000015
Cat. No.: 0500FAH:
12515530, 13000002
Cat. No.: 0500FEH:
13000000, 13000010 - 13000051, 13000061,
13000072 - 13000076, 13000081 - 13000084.
MANUFACTURER Corometrics Medical Systems, Inc.,
Wallingford, Connecticut.
RECALLED BY Manufacturer, by Product Notification letter
on March 6, 1997, and by fax. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 327 monitors were distributed.
REASON The battery operating time has been shown to
be less than the 16 hours specified due to an
integrated circuit (IC) which was found to
draw too much current.
_______________
PRODUCT Passport Monitors with saturated oxygen
measurement (SP02) Capability supplied by
Nellcor Medical Systems, used to monitor CO2,
respiration, temperature, and non-invasive
blood pressure. Recall #Z-444/446-7.
CODE (a) Model No. 0998-00-0095N01 - N04, N41-N44,
N61-64, B01-04, B41-B44, B61-B64;
(b) Model No. 0998-00-0126N01 - N04, N41-N44,
N61-64, B41-B44, B61-B64;
(c) Model No. 0998-00-0133N42.
Recall #Z-444/446-7.
MANUFACTURER Datascope Corp., Paramus, New Jersey.
RECALLED BY Manufacturer, by letter dated August 2, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,046 units were distributed.
REASON Due to a noisy power supply line on the
Passport, the Nellcor SP02 module provides low
readings of SP02.
-12-_______________
PRODUCT Novametrix Model 520A Oxypleth Pulse Oximeter
with software version 2.6, used to provide
measurement, display and alert for functional
pulsatile oxygen saturation (SP02) and pulse
rate. Recall #Z-454-7.
CODE Software Version 2.6.
MANUFACTURER Novametrix Medical Systems, Inc., Wallingford,
Connecticut.
RECALLED BY Manufacturer, by letter on March 3, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,364 units were distributed.
REASON There is a software error associated with the
displayed pulse rate alert parameter. Under
certain monitoring set-ups, the actual pulse
rate alert limits set in the monitor may not
be the same as those shown on the display.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Coatest APC Resistance Diagnostic Test Kits.
Recall #Z-427-7.
CODE Type -SC Kits, Lot Nos. X3118 and X3235;
Type -C Kits, Lot. No. X3234.
MANUFACTURER Chromogneix AB, Nykoping, Sweden.
RECALLED BY DiaPharma Group, Inc., Franklin, Ohio
(importer/distributor), by letter on March 19
and 20, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 204 kits were distributed.
REASON The plasma controls in the kits are yielding
results which are out of specification.
_______________
PRODUCT Micro Jewel Arrhythmia Management Device,
Model 7221Cx. Recall #Z-437-7.
CODE MODEL 7221Cx BUILT WITH CONNECTOR MODULE PART
NUMBER 149312-004 FROM THE FOLLOWING LOTS:
Lot No. Serial No.
557723 PFK202624H
571132 PFK200059H
571132 PFK200110H
571513 PFK200260H
571513 PFK200291H
571513 PFK200301H
571513 PFK200304H
571513 PFK200401H
571513 PFK200403H
571513 PFK200444H
-13- Lot No. Serial No.
571513 PFK200447H
572744 PFK200148R
572744 PFK200195R
572744 PFK200270R
572744 PFK200398R
572744 PFK200399R
572744 PFK200449R
572744 PFK200470R
573320 PFK200556R
573320 PFK201432H
Lot No. Serial No.
573320 PFK201483H
573320 PFK201690H
573320 PFK201717H
573320 PFK201718H
573320 PFK201720H
573320 PFK201721H
573320 PFK201722H
573320 PFK201724H
573320 PFK201727H
573320 PFK201728H
573320 PFK201735H
573320 PFK201738H
573320 PFK201748H
573320 PFK201749H
573599 PFK200354H
573599 PFK200373R
573599 PFK200426H
573599 PFK200493H
573599 PFK200520H
573599 PFK200626H
573599 PFK201612H
573599 PFK201661H
573599 PFK201701H
574366 PFK200376H
574366 PFK200578H
574366 PFK200602H
574366 PFK200607H
574451 PFK200555H
574451 PFK200601R
574451 PFK200647H
574451 PFK200655H
574451 PFK200701H
574451 PFK200712R
574451 PFK200779H
574564 PFK200650H
574564 PFK200676H
574564 PFK200679R
574564 PFK200680R
574564 PFK200688H
574564 PFK200688R
-14- 574564 PFK200715H
574564 PFK200724H
574564 PFK200765H
574650 PFK200086R
Lot No. Serial No.
574650 PFK200318H
574650 PFK200581R
574650 PFK200706H
574650 PFK200743H
574650 PFK200848H
574650 PFK200874H
574891 PFK200113H
574891 PFK200856H
574891 PFK200922H
574891 PFK200981H
575083 PFK200888H
575143 PFK200979H
575143 PFK200982H
575143 PFK200993H
575143 PFK200996H
575143 PFK201033H
575143 PFK201141H
575143 PFK201151H
575245 PFK200559H
575245 PFK200592H
575245 PFK200617H
575245 PFK201139H
575245 PFK201142H
575245 PFK201142H
575245 PFK201144H
575245 PFK201268H
575245 PFK201268H
575245 PFK201269H
575353 PFK201252H
575353 PFK201253H
575353 PFK201253H
575353 PFK201258H
575482 PFK201230H
575482 PFK201232H
575482 PFK201254H
575537 PFK201181H
575537 PFK201182H
575537 PFK201231H
575537 PFK201289H
575537 PFK201294H
575599 PFK201511H
575775 PFK201536H
575775 PFK201600H
575776 PFK200499H
Lot No. Serial No.
575776 PFK201368H
575776 PFK201470H
-15- 575776 PFK201608H
575778 PFK201358H
575927 PFK200588H
575927 PFK201444H
575927 PFK201445H
575927 PFK201452H
575927 PFK201491H
575927 PFK201622H
576266 PFK201832H
576266 PFK201879H
576266 PFK201913H
576266 PFK201934H
576266 PFK201958H
576266 PFK201960H
576266 PFK201981H
576266 PFK202121H
576359 PFK201820H
576359 PFK201837H
576360 PFK201657H
576360 PFK201782H
576360 PFK201806H
576360 PFK201862H
576447 PFK201907H
576447 PFK202016H
576482 PFK201225H
576539 PFK201829H
576539 PFK201895H
576539 PFK202105H
576765 PFK202881H
576765 PRK202823H
576901 PFK202187H
576901 PFK202195H
576901 PFK202222H
576901 PFK202228H
576901 PFK202388H
576901 PFK202469H
576986 PFK202034H
576986 PFK202046H
576986 PFK202055H
576986 PFK202060H
576986 PFK202081H
576986 PFK202083H
Lot No. Serial No.
576986 PFK202117H
576986 PFK202170H
576986 PFK202214H
576986 PFK202220H
577090 PFK202436H
577413 PFK202181H
577413 PFK202291H
577413 PFK202323H
577413 PFK202335H
-16- 577413 PFK202338H
577413 PFK202416H
577413 PFK202420H
577413 PFK202437H
577413 PFK202484H
577413 PFK202506H
577413 PFK202533H
577413 PFK202538H
577413 PFK202562H
577413 PFK202594H
577413 PFK202609H
577413 PFK202634H
577413 PFK202635H
577413 PFK202707H
577413 PFK202721H
577413 PFK202743H
577413 PFK202766H
577413 PFK202822H
577723 PFK202604H
577723 PFK202607H
577723 PFK202611H
577723 PFK202615H
577723 PFK202625H
577723 PFK202628H
577723 PFK202670H
577723 PFK202675H
577723 PFK202681H
577723 PFK202692H
577723 PFK202702H
577723 PFK202724H
577723 PFK202734H
577723 PFK202741H
577723 PFK202744H
577723 PFK202826H
577723 PFK202826H
Lot No. Serial No.
577723 PFK202886H
577846 PFK202495H
577846 PFK202503H
577846 PFK202660H
577846 PFK202683H
577846 PFK202732H
577846 PFK202759H
577846 PFK202884H
578985 PFK202799H
578985 PFK202800H
578985 PFK202801H
578985 PFK202803H
578985 PFK202847H
578985 PFK202848H
578985 PFK202852H
578985 PFK202858H
-17- 578985 PFK202863H
578985 PFK202900H.
MANUFACTURER Medtronic Med Rel, Inc., Humacao, Puerto Rico.
RECALLED BY Medtronic, Inc., Minneapolis, Minnesota, by
device retrieval plan dated March 10, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,358 units were distributed.
REASON The device was distributed with
out-of-specification connector header blocks
resulting in device failure due to setscrew
problems.
_______________
PRODUCT Various size colored "TAMPS" for osteochondral
Autograft (5mm, 6mm, 7mm, 8mm, 9mm and 10mm),
Catalog numbers AR-1985-05 through AR-1985-10.
Recall #Z-442-7.
CODE All codes.
MANUFACTURER Arthrex, Inc., Naples, Florida.
RECALLED BY Manufacturer, by letter on February 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 455 units were distributed.
REASON There is a potential for the pin in the tamps
to become dislodged and fall out. If the pin
were to fall out in surgery, it may be hard to
retrieve because of its small size.
-18-
END OF ENFORCEMENT RPORT FOR APRIL 30, 1997. BLANK PAGES MAY FOLLOW.
####
End of Enforcement Report for
![[FDA HOME PAGE]](https://webarchive.library.unt.edu/eot2008/20081006154606im_/http://www.fda.gov/icon/iconhome.gif)