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.
ENFORCE
11/17/1993
Recalls and Field Corrections: Foods -- Class I -- 11/17/1993
November 17, 1993 93-46
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Packaged fish (a) Ocetrina Hot Smoked Sturgeon, sliced and
vacuum packed, approximately 4-ounce packages; (b) Nova
Smoked Salmon sliced and vacuum packaged, approximately 4-
ounce packages. Recall #F-094/095-4.
CODE Lot numbers: (a) 793175; (b) 793165.
MANUFACTURER International Gold Star Trading Corporation, Brooklyn, New
York.
RECALLED BY Manufacturer, by telephone September 14, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 38 pounds - Approximately 152 packages; (b) 164 pounds -
Approximately 656 packages.
REASON The product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Fresh Artichokes, packed in 16.5 pound wooden crates.
Recall #F-221-3.
CODE Each carton has a packed date which varies throughout
October and November 1992.
MANUFACTURER Commercial Abastefrut, Ltd., Curico, Chile and Rafael
Zamorano Acevedo, Curico, Chile (Growers). RECALLED BY Carben, Inc., Miami, Florida, by letter December 21, 1992.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY Firm estimates none remains on the market.
REASON Product was contaminated with Captan.
_______________
PRODUCT Koppers brand Raisins in Dark Chocolate in 7-ounce
containers. Recall #F-048-4.
CODE All lots distributed from January to March 1993.
MANUFACTURER Koppers Chocolate Specialty Company, Inc., New York, New
York.
RECALLED BY Manufacturer, by letter dated September 22, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 134 dozen units were distributed.
REASON Product is mislabeled - Contains Pistachios instead of
labeled raisins.
_______________
PRODUCT Kix Crispy Corn Puffs (breakfast cereal), in boxes holding
13 ounces and 9 ounces. Recall #F-049-4.
CODE Lot numbers: 22MAR94 X212 and 23MAR94 X212 of the 13-ounce
boxes; 23MAR94 X210 of the 9-ounce boxes.
MANUFACTURER General Mills, Inc, South Chicago, Illinois.
RECALLED BY General Mills, Inc., Minneapolis, Minnesota, by memorandum
and press release October 14, 1993. An October 14, 1993
notice, similar to the press release, was issued by the firm
to the Food Allergy Network. The Food Allergy Network
reportedly sent the notice to their members on October 14,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 14,000 cases (16 9-ounce and 14 13-ounce boxes
per case) were distributed.
REASON Product contaminated with pieces of honey nut cherrios,
which contain undeclared almonds.
_______________
PRODUCT Ice cream, all flavors (except vanilla), packed in 3-1/2
gallon containers:
1. Butter Pecan
2. Chocolate Chip
3. Cookies N' Cream
4. Peaches N' Peach
5. Natural Strawberry
5. Cherry Cordial
6. Mint Chocolate Chip
7. P Butter N' Chip
9. Chocolate Chip Cookie Dough
10. English Toffee Bar
11. Honey N Cashew Bulk
-2- 12. Yogurt Cookies
13. Peach Melba
14. Car. Pecan Fudge
15. Strawberry Yogurt
16. Milk Chocolate Yogurt
17. No Name Candy Bar
18. Chocolate
19. Strawberry
20. Whitehouse
21. Chocolate Marshmallow
22. Swiss Chocolate
23. Fudge Nut Sundae
24. Mint Chip
25. Orange Sherbet
26. Pineapple Sherbet
27. Rainbow Sherbet
28. Strawberry Sherbet
29. Peach
30. Strawberry Cheesecake
31. Lemon Lime
32. Lime Sherbet
33. Vanilla Orange
34. Peppermint Stick
35. DBL Chocolate Malted
36. Pnut Bric Crunch
37. Pnut Butter Fudge. Recall #F-054/090-4.
CODE All lot numbers.
MANUFACTURER United Dairy Farmers (UDF), Cincinnati, Ohio.
RECALLED BY Manufacturer, by having store supervisors visually inspect
all stock on September 17, 1993. Firm-initiated recall
complete.
DISTRIBUTION Kentucky, Ohio.
QUANTITY Approximately 12,000 3-1/2 gallon containers were
distributed.
REASON Product is contaminated with ammonia.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Heller's brand Nitrite/Phosphate cure, used on meat and
fish. 3.5 pounds. Recall #F-053-4.
CODE Date 5/17/93 - No lot number on label.
MANUFACTURER Heller Seasonings & Ingredients, Bethlehem, Pennsylvania.
RECALLED BY Manufacturer, by letter June 9, 1993, followed by telephone.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 20 twin packs were distributed.
REASON Product lacks the labeled ingredient sodium nitrite.
_______________
PRODUCT Shop Rite brand Diet Ginger Ale, in 16-ounce bottles.
Recall #F-092-4.
-3- CODE ****/012193 - All products with the second line as 012193.
MANUFACTURER Premium Beverage Packers, Inc., Wyomissing, Pennsylvania.
RECALLED BY Manufacturer, by telephone October 26, 1992. Firm-initiated
recall complete.
DISTRIBUTION New Jersey.
QUANTITY Firm estimates none remains on the market.
REASON Product was mislabeled - Does not contain declared
Aspartame.
_______________
PRODUCT NutriSystem Artificially Flavored Blueberry Muffins with
imitation blueberry bits, in 2-ounce packages each
containing 3 muffins. Recall #F-093-4.
CODE All codes.
MANUFACTURER Pewter Pot Muffin Company, Waltham, Massachusetts.
RECALLED BY Nutri/System, Bluebell, Pennsylvania, by letter September
16, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Missouri, Massachusetts.
QUANTITY Firm estimates less than 1,000 cases of product remain on
the market.
REASON Product is contaminated with mold.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT DMSA Kidney Reagent Kit for the preparation of Technetium
TC99m Succimer Injection, Rx intravenous sterile diagnostic
radiopharmaceutical. Recall #D-023-4.
CODE Lot numbers: 002, 002A, 002B.
MANUFACTURER Amersham International plc, Gloucester, England.
RECALLED BY Medi-Physics, Inc., Arlington Heights, Illinois, by letter
October 12, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 724 kits were distributed; firm estimates 150 kits remain on
the market.
REASON Kits bear an expiration date of March 24, 1994 instead of
Sept 24, 1993.
_______________
PRODUCT Videx (Didanosine) Chewable/Dispersible Buffered Tablets, 25
mg, in 60 tablet bottles, Rx, used in the treatment of AIDS.
Recall #D-025-4.
CODE Batch code MBE15.
MANUFACTURER Bristol-Myers Squibb Company, Evansville, Indiana.
RECALLED BY Bristol-Myers Squibb HIV Products, Princeton, New Jersey, by
letter June 3, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 207 cases (12 bottles per case) were distributed.
REASON Product does not meet content uniformity specifications.
-4- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Novafed, brown and orange colored hard gelatin capsules, in
bottles of 100, a controlled release Rx decongestant.
Recall #D-024-4.
CODE Lot #1127BC EXP 12/94.
MANUFACTURER KV Pharmaceuticals, St. Louis, Missouri.
RECALLED BY Marion Merrell Dow, Inc., Cincinnati, Ohio, by letter
October 7, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 19,467 bottles were distributed; firm estimates very little
stock remains on the market.
REASON Product failed stability testing for dissolution.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c) Recovered
Plasma. Recall #B-011/-013-4.
CODE Unit numbers: (a) 0238177, 0239878, 0240652, 0244526,
0244920, 4414079; (b) 0231555, 0233859, 0236282, 0238811,
0239878, 0240652, 0244526, 0244920; (c) 0238177, 4414079.
MANUFACTURER Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY Manufacturer, by letters between February 21, 1992 through
March 1993. Firm-initiated recall complete.
DISTRIBUTION Washington state, Idaho, California, North Carolina.
QUANTITY (a) 6 units; (b) 8 units; (c) 2 units.
REASON Blood products which tested negative for human
immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1; tested improperly for the hepatitis
B surface antigen (HBsAg); were collected from a donor
reporting recent ear piercing by a non-sterile method; were
collected as a therapeutic bleed, but were not labeled to
reflect the donor's condition.
_______________
PRODUCT Recovered Plasma. Recall #B-016-4.
CODE Unit #X44263.
MANUFACTURER Central California Blood Bank, Fresno, California.
RECALLED BY Manufacturer, by telephone February 25, 1991, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product which tested repeatedly reactive for the
hepatitis B surface antigen (HBsAg), and initially reactive
to hepatitis B core antigen (anti-HBc), with no repeat
testing, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-030-4.
CODE Unit 20G96737.
-5- MANUFACTURER American Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, by letter December 21, 1990. Firm-initiated
recall ongoing.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Red Blood Cells, collected from a donor who traveled to an
endemic area for malaria less than three months prior to
donation, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-040/042-4.
CODE Unit numbers: (a) 53KL22382, 53KT29582; (b) 53F73602; (c)
53KL22382, 53KT29582.
MANUFACTURER The American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letters of October 29, 1992, November 4 and
18, 1992, and March 18, 1993, and by telephone March 2,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Washington, D.C., Maryland, California, Switzerland.
QUANTITY (a) 2 units; (b) 1 unit; (c) 2 units.
REASON Blood products, which either tested non-reactive 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; or contained
alloantibodies, but were labeled as negative for unexpected
antibodies, were distributed.
_______________
PRODUCT Vironostika HIV-1 Microelisa System Test Kits, used in the
quantitative determination of antibody to HIV-1 in human
serum. Recall #B-043-4.
CODE Lot numbers 120584 and 141571.
MANUFACTURER Organon Teknika Corporation, Durham, North Carolina.
RECALLED BY Manufacturer, by telephone and by letters dated June 24,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, The Netherlands.
QUANTITY 670 kits were distributed.
REASON Antibody to human immunodeficiency virus type 1 (anti-HIV-1)
test kits, containing wash concentrate incorrectly labeled
as diluent concentrate, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-045/046-4.
CODE (a) 4129775, 4130538, 4131569, 4132113, 4132622, 4133133,
4133675, 4134154, 4134711; (b) 4129775, 4130538, 4131052,
4131569, 4132113, 4132622, 4133133, 4133675, 4134154,
4134711.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY Manufacturer, by letter August 10, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Florida, Massachusetts, Alabama.
-6- QUANTITY (a) 9 units; (b) 10 units.
REASON Blood products, which 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, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-047-4.
CODE Unit numbers: 0002548, 0004188, 0006095.
MANUFACTURER Community Blood Center, Naples, Florida.
RECALLED BY Manufacturer, by letters of March 2, 1993, and April 2,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida, California, New Jersey.
QUANTITY 3 units.
REASON Blood products, which 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, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-048/049-4.
CODE Unit numbers: (a) 04H92258; (b) 04H92258.
MANUFACTURER The American National Red Cross, Dedham, Massachusetts.
RECALLED BY Manufacturer, by telephone July 23, 1991, followed by letter
dated August 14, 1991. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit of each component.
REASON Blood products, that tested initially reactive for syphilis
and were not retested in accordance with the manufacturer's
test kit instructions, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-014-4.
CODE Unit numbers: 2223814 and 1159314.
MANUFACTURER Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY Manufacturer, by letters between February 21, 1992 through
March 1993. Firm-initiated recall complete.
DISTRIBUTION Idaho, Washington state.
QUANTITY 2 units.
REASON Blood products which tested improperly for HBsAg; or were
labeled with the incorrect expiration dates were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-026/027-4.
CODE Unit #CF0104306.
MANUFACTURER Cape Fear Valley Medical Center, Fayetteville, North
Carolina.
-7- RECALLED BY Manufacturer, by letter and telephone August 10, 1993.
Firm-initiated recall complete.
DISTRIBUTION North Carolina, Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which were not tested for Hepatitis B
surface antigen (HBsAg), and the antibodies to the human
immunodeficiency virus type 1/2 (anti-HIV-1/2) and human T-
lymphotropic virus type I (anti-HTLV-I), were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c) Recovered
Plasma. Recall #B-037/039-4.
CODE Unit numbers: (a) 36LP01166, 36LP01170, 36LP01171,
36LP01172, 36LP01173, 36LP01174, 36LP01175, 36LP01176,
36LP01177, 36LP01178, 36LP01179, 36LP01180, 36LP01181,
36LP01182, 36LP01183, 36LP01185, 36LP01186, 36LP01187,
36LP01188, 36LP01189, 36LP01190, 36LP01191, 36LP01193,
36LP01194, 36LP01195, 36LP01196, 36LP01197, 36LP01198,
36LP01199; (b) 36LP01178, 36LP01179, 36LP01185, 36LP01187;
(c) 36LP01171, 36LP01172, 36LP01173, 36LP01197.
MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina.
RECALLED BY Manufacturer, by letter May 17, 1993. Firm-initiated recall
complete.
DISTRIBUTION South Carolina, Georgia.
QUANTITY (a) 29 units; (b) 4 units; (c) 4 units.
REASON Blood products, collected from donors who received monetary
payment for donating, were mislabeled as volunteer donations
and distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Laerdal Silicone Resuscitators:
(a) Laerdal Silicone Resuscitators, Catalog numbers:
850000, 850001, 850005, 850016, 860000, 860001, 860003,
860005, 870000, 870001, 870005, 870016;
(b) Non-rebreathing Valve Assemblies and individual Lip
Membranes, Catalog Numbers 851200, 560200, 540103.
Recall #Z-768/769-3.
CODE Lot numbers: 1293, 1393, 1593, 1793, 1893, 1993, 2193,
2393.
MANUFACTURER Laerdal Medical Corporation, Armonk, New York
RECALLED BY Manufacturer, by telephone and by letter on June 30, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,749 units.
REASON Some lip membranes in the silicone resuscitators may
partially collapse resulting in partial blockage of the
expiratory gas pathway.
-8- _______________
PRODUCT Sechrist Model 2200B Ventilator. Recall #Z-060-4.
CODE Serial numbers: 91596 to 91655, 91657 to 91745, 91760 and
91762.
MANUFACTURER Sechrist Industries, Anaheim, California.
RECALLED BY Manufacturer, by letters from April 7, 1993 through April
27, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Puerto Rico, Texas, New Jersey, Florida, California and
international.
QUANTITY 151 units.
REASON A software problem can cause a serious error in the tidal
volume delivered to the patient.
_______________
PRODUCT Nucletron MicroSelectron-HDR and MicroSelectron-PDR System,
used in the treatment of radiation therapy.
Recall #Z-085/086-4.
CODE All lots.
MANUFACTURER Nucletron B.V., Waardgelder 1, The Netherlands.
RECALLED BY Nucletron Corporation, Columbia, Maryland, by technical
notes on October 5, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 242 high dose rate units.
REASON There is a safety feature that checks for the presence of a
applicator using a photo-detector that has been known to
fail. If this failure mode occurs and the catheter or
applicator is incorrectly placed in a channel other than the
one for which it is programmed, the machine may send out the
cable or source, resulting in misadministration of dosage to
the patient.
_______________
PRODUCT Gamma Nail Instrument, K-Wire 3.2 mm x 450 mm, used in the
treatment of unstable proximal femoral fractures.
Recall #Z-087-4.
CODE Reference 1210-6450.
MANUFACTURER Howmedica GMbH, Germany.
RECALLED BY Howmedica, Division of Pfizer Hospital Products Group, Inc.,
Rutherford, New Jersey, by telephone July 16, 1992. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 201 units.
REASON The package is labeled as Cat 3371-1-0600, size 3.2 mm x 450
mm in length, but some packages contain a guide wire that is
440 mm in length.
_______________
PRODUCT Inflatable penile prosthesis preparation packages:
(a) American Medical Systems Inflatable Penile Prosthesis
Package (Needles/Tubing), Product No. 72400001;
-9- (b) American Medical Systems Sphincter 800 Urinary
Prosthesis Preparation Package (Needles/Tubing/Cuff Sizer),
Product No. 72400002;
(c) American Medical Systems Malleable 600 Penile
Prosthesis, 20 cm, Product No. 72400142;
(d) American Medical Systems Ultrex 100ml Reservoir, Product
No. 72401130;
(e) American Medical Systems Sphincter 800 Securo-T Urinary
Prosthesis (Artificial Sphincter), Product No. 72401811.
Recall #Z-089/093-4.
CODE Lot numbers
(a) 6919P 7112P 7113P 7114P
7115P 7116P 7117P 7118P
7452P 7453P 7773P 7774P
7775P 8959P 7776P 7454P
7455P 7456P 7458P 8480P
8481P 8482P 8483P 8960P
8961P 8962P 9729P 9728P
9730P 0088Q 9727P 0091Q
0089Q 0090Q 0276Q 7457P
0594Q 0277Q 0278Q 0279Q
0593Q 0595Q 0596Q 0597Q
0731Q 0559Q 0598Q 0726Q
0727Q 0728Q 0725Q 0729Q
0870Q 0871Q 0875Q 0869Q
1001Q 0114Q 1005Q 0730Q
0872Q 1002Q 1003Q 1006Q
1007Q 0873Q 0874Q 1117Q
1118Q 1119Q 1120Q 1121Q
1122Q 1123Q 1465Q 1466Q
1643Q 1467Q 1468Q 1642Q
1769Q 1771Q 1772Q 1967Q
1770Q 1968Q 1969Q 1970Q
1971Q 2165Q 2169Q 1768Q
2166Q 2167Q 2168Q 2425Q
2426Q 2427Q 2429Q 2572Q
4506Q 2568Q 2570Q 2170Q
2428Q 2569Q 2571Q 2573Q
2430Q 2659Q 2661Q 2662Q
2663Q 2664Q 2743Q 2745Q
2918Q 2920Q 2660Q 2742Q
2744Q 2746Q 2919Q 4505Q
2921Q 2922Q 3031Q 3032Q
3033Q 3034Q 3035Q 3132Q
3130Q 3131Q 3172Q 3174Q
3175Q 3334Q 0038T 3173Q
3176Q 3338Q 0035T 0036T
0037T 0115T 0116T 0117T
3335Q 3337Q 0039T 3336Q
0134T 0135T 0358T 0401T
0404T 0133T 0359T 0360T
0361T 0402T 0403T 0556T
-10- 0558T 0555T 0557T 0768T
0771T 0769T 0948T 0770T
0945T 0946T 0947T 4605T
1123T 1126T 1122T 1124T
1125T 1275T 1273T 1274T
1305T 1306T 1307T 1646T
1645T 1644T 2216T 2217T
2218T 2219T 2644T 2645T
2646T 2647T 2737T 2739T
2743T
(b) 8484P 8485P 8963P 8964P
9553P 9554P 9732P 9733P
0280Q 0600Q 0601Q 0092Q
0093Q 0281Q 0733Q 0877Q
0732Q 0876Q 1008Q 1009Q
1124Q 1125Q 1470Q 1471Q
1645Q 1646Q 1647Q 1773Q
1774Q 1775Q 1972Q 1974Q
1973Q 2172Q 2171Q 2431Q
2432Q 2574Q 2665Q 2575Q
2666Q 2747Q 2748Q 2923Q
2924Q 3036Q 2027Q 3133Q
3343Q 3177Q 3339Q 0041T
3178Q 3340Q 0040T 0018T
0137T 0406T 0363T 0362T
0136T 0405T 0559T 0560T
0772T 0773T 0949T 0950T
1127T 4613T 1128T 1276T
1277T 1308T 1309T 1648T
1647T 1805T 1506T 2659T
2658T 2660T 2661T 2662T
2745T 2746T 2748T 2751T
2907T 2747T 2750T 2752T
2904T 2749T 2903T 2905T
2906T 3115T 3116T 3117T
3119T 4750R 3134T 4754R
(c) 2438Q 2778Q 1137T 1642T
2582Q 3137Q 1280T 1643T
2178Q 0565T 1281T 1811T
4526R 0566T 4610R 1967T
2439Q 0954T 1312T 1968T
2671Q 0955T 1313T 2476T
2672Q 1136T
(d) 4148R 7952P 7547P 7549P
7550P 9094P 8627P 8628P
8707P 8708P 9093P 9095P
9566P 9567P 9568P 9569P
9570P 9571P 9792P 9793P
9794P 9795P 9933P 9934P
9935P 9936P 9937P 9938P
9939P 0179Q 0180Q 0181Q
0182Q 0392Q 0393Q 0394Q
-11- 0391Q 0657Q 0658Q 0659Q
0660Q 0777Q 0779Q 0776Q
0778Q 0962Q 0963Q 0964Q
0965Q 1167Q 1168Q 1169Q
1170Q 1377Q 1378Q 1379Q
1380Q 1381Q 1492Q 1494Q
1495Q 1490Q 1493Q 1679Q
1682Q 1684Q 1680Q 1681Q
1901Q 1902Q 2495Q 1896Q
1900Q 1903Q 1904Q 2089Q
2090Q 2091Q 2092Q 2093Q
2094Q 2496Q 2497Q 2498Q
2499Q 2500Q 2501Q 2320Q
2322Q 2323Q 2324Q 2325Q
2326Q 2327Q 2328Q 2329Q
2631Q 2632Q 2634Q 2636Q
2637Q 2731Q 2633Q 2635Q
2727Q 2730Q 2725Q 2726Q
2728Q 2729Q 2850Q 2851Q
2852Q 2853Q 2854Q 2849Q
3011Q 3016Q 3012Q 3014Q
3013Q 3015Q 3018Q 3019Q
3017Q 3020Q 3022Q 3021Q
2321Q 3364Q 3368Q 3363Q
3367Q 3432Q 3365Q 3366Q
3435Q 4546R 0282T 0283T
3431Q 3433Q 3434Q 3436Q
0483T 0485T 0484T 0616T
0617T 0718T 0720T 0719T
0941T 0940T 0942T 1118T
1117T 1119T 1246T 1247T
1505T 1506T 1507T 1630T
1631T 1632T 1795T 1796T
1797T 1910T 1911T 1912T
2023T 2024T 2269T 2022T
2265T 2267T 2268T 2266T
2395T 2397T 2398T 2619T
2620T
(e) 3044T 3045T 3043T 3165T 3302T.
MANUFACTURER American Medical Systems, Pfizer Hospital Products Group,
Minnetonka, Minnesota.
RECALLED BY Manufacturer, by letter July 28, 1993. Firm-initiated
recall ongoing
DISTRIBUTION Nationwide and international.
QUANTITY (a) 9,848 units; (b) 3,896 units; (c) 353 units; (d) 1,965
units; (e) 90 units.
REASON The Tyvek lids of the sterile packaging of some of the
product units separated from the plastic trays of the
sterile packaging, therefore rendering the devices
unsterile.
-12- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Hoffman Mini-Swivel Clamps for external fixation of distal
radius fractures:
(a) Catalog #5079-1-110; (b) Catalog #5079-1-120.
Recall #Z-013/014-4.
CODE None.
MANUFACTURER Jaquet Orthopedie SA, Geneva, Switzerland.
RECALLED BY Howmedica Division, Pfizer Hospital, Product Group Inc.,
Rutherford, New Jersey, by letter November 25, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 93 units; (b) 268 units were distributed; firm estimates
(a) 75 units; (b) 200 units remain on the market.
REASON The clamps fail to tighten sufficiently causing the external
fixation frame to be unstable.
_______________
PRODUCT Micro Ventricular Bolt Pressure Monitoring Kit Model 1109-
4HM, used to provide a means of access to the cerebral
ventricles for CSF sampling and drainage, fluid injection
and intracranial pressure monitoring. Recall #Z-059-4.
CODE Sterilization lot numbers: D2004, E2004, E2005, F2002,
F2003, C3002, G2001-G2004, H2001, H2004, I2001-I2004, J2001-
J2005, K2001-K2004, L2001-L2004, A3001, A3002, B3001.
MANUFACTURER Camino Laboratories, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter April 23, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Denmark, Great Britain, Holland, Canada, Spain,
New Zealand, Germany.
QUANTITY 3,377 units.
REASON The package is labeled for Model 110-4HM, while the stylets
in the package are for Model 110-4H, which are too short to
hold the introducer rigid for proper access to the
ventricles.
_______________
UPDATE Ortho brand, Round Bottom , MRC-5 Human Embryonic Lung,
(Diploid) Cell Culture Tubes, which appeared in the November
10, 1993 Enforcement Report should read Product #505050, lot
#063050 EXP 6/29/93.
MASS SEIZURE:
=============================================================
_______________
PRODUCT Basmati rice, lentils, mung beans, spices, and all other
food products in insect susceptible containers
(94-710-287, et al.).
CHARGE Adulterated - The articles have been held under insanitary
conditions whereby they may have become contaminated with
filth.
FIRM House of Spices, Inc., Elk Grove Village, Illinois.
-13- FILED October 22, 1993; U.S. District Court for the Northern
District of Illinois; Civ. #93C 6467; FDC #66799.
SEIZED October 25, 1993 - goods valued at approximately $250,000.
SEIZURES:
================================================================
_______________
PRODUCT Raw and roasted chickpeas, tamarind concentrate, and basmati
rice (93-709-874, et al.).
CHARGES Adulterated - The tamarind concentrate contains insects,
insect fragments, mites, and feather barbules; and, the raw
chickpeas, roasted chickpeas and basmati rice have been held
under insanitary conditions whereby they may have become
contaminated with filth.
FIRM International Golden Foods, Inc., Niles, Illinois.
FILED October 22, 1993; U.S. District Court for the Northern
District of Illinois, Civ. #93-C-6465; FDC #66795.
SEIZED November 4, 1993 - goods valued at approximately $3,700.
_______________
PRODUCT Latex surgical and examination gloves (93-610-624/9).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, packing, and
storage are not in conformity with current good
manufacturing practice regulations.
FIRM American Pro Latex, Inc., Monmouth, Illinois.
FILED October 4, 1993; U.S. District Court for the Central
District of Illinois; Civ. #93-4085; FDC #66766.
SEIZED October 26, 1993 - goods valued at approximately
$30,000.
-14-
END OF ENFORCEMENT REPORT FOR NOVEMBER 17, 1993. BLANK PAGES MAY
FOLLOW.
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