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.
August 12, 1998
98-32

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

PRODUCT
Raw, Whole, Waxed Sweet Potatoes, in 40 pound bags. Recall #F-567-8.

CODE
None. All product shipped up to 6/19/98.

MANUFACTURER
Burch Farms, Faison, North Carolina.

RECALLED BY
Manufacturer, by telephone on June 19, 1998, followed by letter. Ongoing recall resulted from sample analysis and follow-up by the Georgia Department of Agriculture, and the North Carolina Department of Agriculture.

DISTRIBUTION
Florida, Georgia, Kentucky, Maryland, New York, North Carolina, Pennsylvania, Virginia.

QUANTITY
Undetermined.

REASON
Product contains dicloran pesticide residue in excess of the established tolerance of 10 ppm.

PRODUCT
Fresh Blackberries, in 6 ounce containers. Recall #F-568-8.

CODE
71-1264, 71-1265, 71-1266, 71-1267, 71-1271, 71-1272.

MANUFACTURER
J.E. Farms, Inc., Watsonville, California (producer).

RECALLED BY
Driscoll Strawberry Associates, Inc., Watsonville, California, by fax on July 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
7,339 flats (12 6-ounce containers per flat) were distributed.

REASON
Product contains a triadimefon - a pesticide which is not allowed for use on blackberries.

PRODUCT
Imagine Natural Garden Vegetable Soup - Creamy Mushroom Soup, in 1 quart aseptic carton. Recall #F-566-8.

CODE
Pull dates: 3/3/1999 and 4/2/1999.

MANUFACTURER
California Natural Products, Lathrop, California.

RECALLED BY
Imagine Foods, Inc., Palo Alto, California, by letter on July 9, 1998, followed by press release on July 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
6,050 cases (12 packages per case) were distributed.

REASON
Product contains undeclared soybeans.

PRODUCT
Products containing green pepper strips: a) Frozen green pepper strips, packed in bulk 20-lb. cases. The cases are identified with a ink jet printer. The cases are identified, 1 x 20 lb Chef's Garden Green Pepper Strips 33166. The responsible firm on the label is Interfrost, Inc., E. Rochester, NY. b) Frozen red and green pepper strips and onions, packed in 16 oz. plastic bags, 12 bags to a shipping case. There are two brand names, DeMoulas and Weis. For both brands the product is known as Pepper and Onion Stir Fry c) Frozen red and green pepper strips, packed in 8 oz. plastic bags, 12 bags to a shipping case. There are two brand names, DeMoulas and Weis. The product is labeled as Pepper Strips for the DeMoulas brand and labeled as Mixed Pepper Strips for the Weis brand. Recall #F-569/571-8.

CODE

(a)  The code, H59 33166, is applied by an ink jet printer to 
     the outside of the cardboard case.
(b)  Demoulas brand:  H59 32956, H59 33007 and H59 33158;
     Weis brand:  H59 32932 
(c)  Demoulas brand:  H59 33118, H59 33156, and H59 33245; 
     Weis brand: H59 32929 and H59 33099.

MANUFACTURER
Interfrost, Inc., Holly, New York (repacker); Virto S.A., Azagra, Spain (supplier of green pepper strips).

RECALLED BY
Interfrost, Inc., East Rochester, New York, by telephone, followed by letter dated July 21, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Vermont, Pennsylvania, Massachusetts.

QUANTITY

a) 100/20-lb. cases 
b) DeMoulas brand: 250 cases (12 per case)
   Weis brand: 126 cases (12 per case)     
c) DeMoulas brand: 450 cases (12 per case)
   Weis Brand: 360 cases (12 per case).

REASON
Product contains procymidone - a pesticide which is not allowed for use on green peppers.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

PRODUCT
Penicillin-VK, Penicillin V Potassium Powder for Oral Solution, 125 mg (200,000 U) per 5 mL, in 100 mL bottles, under the Biocraft label, Rx, used for the treatment of mild to moderately severe infections due to penicillin-G sensitive microorganisms. Recall #D-211-8.

CODE
Lot #39286 EXP 1/99.

MANUFACTURER
Biocraft Laboratories, Inc., Elmwood Park, New Jersey.

RECALLED BY
TEVA Pharmaceuticals USA, Inc., Sellersville, Pennsylvania, by letter on June 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
14,256 bottles were distributed.

REASON
Stability - data may not support labeled expiration date.

PRODUCT
Collyrium for Fresh Eyes, Eye Wash, (borate solution). NDC #: 00008-0769-01. Recall #D-217-8.

CODE

3950841 (EXP 7/98)           3970147 (EXP 2/00)
3950980 (EXP 8/98)           3970209 (EXP 2/00)
3951149 (EXP 9/98)           3970310 (EXP 4/00)
3951148 (EXP 10/98)          3971386 (EXP 4/00)
3951215 (EXP 10/98)          3971032 (EXP 4/00)
3951216 (EXP 10/98)          3971591 (EXP 5/00)
3960020 (EXP 12/98)          3971363 (EXP 7/00)
3960039 (EXP 1/99)           3971433 (EXP 8/00)
3960040 (EXP 2/99)           3971647 (EXP 9/00)
3960382 (EXP 4/99)           3971750 (EXP 10/00)
3961288 (EXP 9/99)           3971936 (EXP 11/00)
3961765 (EXP 9/99)           3981046 (EXP 12/00)
3961509 (EXP 10/99)          3981075 (EXP 1/01)
3961988 (EXP 11/99)          3981379 (EXP 1/01)
3961913 (EXP 12/99)

MANUFACTURER
Wyeth-Ayerst Laboratories, Rouses Point, New York (responsible firm).

RECALLED BY
Wyeth-Ayerst Laboratories, Richmond, Virginia, by letter dated July 15, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

1,923,379 bottles were distributed.

REASON
Contamination - Product contains trace amounts of benzophenone (varnish component of bottle label).

PRODUCT
Nifedipine Soft Gelatin Capsules, USP, 20 mg., in 300 and 1,000 capsule bottles, Rx antianginal. NDC #57664-873-11, NDC #57664-873-18. Recall #D-219-8.

CODE
Lot numbers: 7JY06L EXP FEB 00 (300's) and 8MA18C EXP FEB 00 (1,000's).

MANUFACTURER
R.P. Scherer, St. Petersburg, Florida.

RECALLED BY
Caraco Pharmaceutical Laboratories, Inc., Detroit, Michigan (repacker), by telephone on June 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide

QUANTITY

723 300-capsule bottles and 20 1,000-capsule bottles were distributed.

REASON
Some capsules may not contain any drug ingredient.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

PRODUCT
Triamcinolone Acetonide Cream USP, 0.5%, in 15 gram tubes, Rx topical corticosteroid. NDC #49158-141-20. Recall #D-210-8.

CODE

Lot numbers: M267 EXP 1/2002 and K910 EXP 6/2001.

MANUFACTURER
Thames Pharmacal Company, Ronkonkoma, New York.

RECALLED BY
Manufacturer, by letter mailed on July 6, 1998, followed by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
New York, California, Colorado, Florida, Indiana, Michigan, Ohio, Texas, Puerto Rico.

QUANTITY
28,116 units of lot M267 and 1,641 units of lot K910 were distributed.

REASON
Mispackaging - Some tubes of 0.1% cream were packaged into cartons labeled as 0.5%.

PRODUCT
Meperidine Hydrochloride Injection, USP, 100 mg/mL, in 20 mL vials, Rx, sterile narcotic analgesic for intramuscular, subcutaneous, or slow intravenous injection, under the Steris and Schein labels. NDC# 0402-0948-20; NDC #0364-3027-55. Recall #D-212-8.

CODE
Lot #96N790.

MANUFACTURER
Steris Laboratories, Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on June 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arkansas, Arizona, California, Georgia, Idaho, Indiana, Minnesota, Missouri, Mississippi, New York, Oregon, South Carolina, Tennessee, Texas, Wisconsin.

QUANTITY
3,237 vials were distributed.

REASON
Manufacturing deviations (unapproved batch size).

PRODUCT
Morphine Sulfate Injection, USP, 15 mg/mL, in 20 mL multiple dose vials, Rx, a potent centrally active analgesic. NDC #0364-2366-55. Recall #D-213-8.

CODE
Lot #97B980.

MANUFACTURER
Steris Laboratories, Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on June 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
28,982 vials were distributed.

REASON
Manufacturing deviations (unapproved potency adjustment).

PRODUCT
Progesterone Injection, USP, 50 mg/mL, in 10 mL multiple dose vials, Rx, under the following labels: Steris: NDC 0402-0379-10 Zenith Goldline: NDC 0182-0862-63 Rugby: NDC 0536-7400-70 Paddock Labs: NDC 0574-0704-10 Eveready Drugs: NDC 57548-379-10 United Research Laboratories: NDC 0677-0301-21 Schein: NDC 0364-6683-54. Recall #D-214-8.

CODE
Lot 97F450 (applies to all labels).

MANUFACTURER
Steris Laboratories, Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter sent on June 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada, Puerto Rico, South Africa.

QUANTITY
71,454 vials were distributed.

REASON
Manufacturing deviations (unapproved potency adjustment).

PRODUCT
Cyanocobalamin Injection, USP, 1000 mcg/mL, in 30 mL multiple dose vials, Rx, sterile solution of injectable vitamin B-12, under the following labels: Steris Label: NDC 0402-0091-30 Moore Medical Label: NDC 0839-5661-36 Clint Pharmaceuticals Label: NDC 55553-091-30 United Research Laboratories Label: NDC 0677-0323-23 Zenith Goldline Label: NDC 0182-0202-66 Besse Medical Label: NDC 53614-091-30 Schein Canada Label: DIN 02229972 Keene Pharmaceuticals: NDC 0588-5215-90 Schein USA Label: NDC 0364-6651-56 The product is also packaged for export under the CYTEX LABEL. Recall #D-215-8.

CODE
Lot Number 97D690, expires 3/2000 (applies to all labels)

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on June 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
62,635 vials were distributed.

REASON
Manufacturing deviations (unapproved potency adjustment).

PRODUCT
Zenith Goldline brand Hydrocodone Bitartrate and Phenylpropanolamine Hydrochloride Pediatric Syrup (Hydrocordone Bitartrate 2.5 mg/Phenylpropanolamine Hydrochloride 12.5 mg), in 1 pint bottles, Rx. NDC #0182-1153-40. Recall #D-216-8.

CODE
Lot numbers: 21754A and 21754F.

MANUFACTURER
Morton Grove Pharmaceuticals, Morton Grove, Indiana (contract manufacturer).

RECALLED BY
Zenith Goldline, Miami, Florida (responsible firm), by letter mailed on June 11, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
336 pints of lot 21754A and 70 pints of lot 21754F were distributed.

REASON
Mislabeling - Pediatric strength bears the NDC code for the adult strength.

PRODUCT
Hydrocortisone 10 mg (1%) and Acetic Acid 20 mg (2%)Otic Solution USP, 10 mL size, Rx, Sterile, otic solution for treatment of infections of the external auditory canal. NDC #24208-319-10. Recall #D-218-8.

CODE

Lot Number          Expiration Dates
883551              6/98
903151              8/98
933511              8/98
933521              8/98.

MANUFACTURER
Bausch and Lomb Pharmaceuticals, Inc., Tampa, Florida.

RECALLED BY
Manufacturer, by letter on May 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
33,643 bottles were distributed; firm estimated that 1,000 bottles remained on market at time of recall initiation.

REASON
Impurity specifications may not be met during labeled shelf life.

PRODUCT
Grapefruit Diet Pill Plan Tablets (Phenylpropanolamine HCL, 12.5mg), in bottles of 90, 270 and 540 tablets, OTC drug product, by virtue of the active ingredient, to be used as an aid for effective appetite control to assist in weight reduction. Recall #D-220-8.

CODE
Lot# 800037, EXP 5/00 printed on bottle labels.

MANUFACTURER
ION Labs, Inc., Pinellas Park, Florida.

RECALLED BY
Manufacturer, by letter dated June 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
439 90-count bottles; 328 270-count bottles; and 483 540-count bottles were distributed.

REASON
Label misleading - Bottle label indicates 75 mg phenylpropanolamine HCL on front panel and lists two tablets contain 25 mg in ingredient listing.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

PRODUCT
Red Blood Cells. Recall #B-1357-8.

CODE
Unit #55S85492.

MANUFACTURER
American Red Cross Blood Services, Little Rock, Arkansas.

RECALLED BY
Manufacturer, by telephone and letter on May 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arkansas.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
Platelets, Pheresis, Irradiated. Recall #B-1390-8.

CODE
Unit 21P77503.

MANUFACTURER
American Red Cross, Portland, Oregon.

RECALLED BY
Manufacturer, by telephone on March 24, 1998, and by letter dated March 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon.

QUANTITY
1 unit was distributed.

REASON
Blood product was mislabeled as CMV antibody negative.

PRODUCT
Source Plasma. Recall #B-1395-8.

CODE
Unit #6030025300.

MANUFACTURER
Premier BioResources, Inc., Corpus Christi, Texas.

RECALLED BY
Manufacturer, by visit on October 21, 1996. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
1 unit was distributed.

REASON
Failure to quarantine a blood product that tested negative for anti-HIV-1/2, which was collected from a donor who subsequently tested initially reactive for anti-HIV-1/2.

PRODUCT
Source Plasma. Recall #B-1396-8.

CODE
Unit #6030025305.

MANUFACTURER
Premier BioResources, Inc., Corpus Christi, Texas.

RECALLED BY
Manufacturer, by visit on October 21, 1996. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product tested repeatedly reactive for anti-HCV, and was not subject to additional testing.

PRODUCT
Red Blood Cells. Recall #B-1397-8.

CODE
Unit numbers: KC52577, KC53961, KC55483, KC56969.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letter dated July 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
4 units were distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
Red Blood Cells. Recall #B-1400-8.

CODE
Unit #17183-4932.

MANUFACTURER
United Blood Services, McAllen, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated June 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1403/1405-8.

CODE
Unit numbers: a) 42FT50044, 42FG35429; b) 42FT50044; c) 42FT50044, 42FG35429.

MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY
Manufacturer, by letter dated June 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio and California.

QUANTITY
a) 2 units; b) 1 unit; c) 2 units were distributed.

REASON
Blood products tested negative for the antibody to the human T-lymphotropic virus type I (anti-HTLV-I), but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-1, and initially reactive for anti-HTLV-1, on two occasions.

PRODUCT
Sanguin MEDUSA 2000 Assay Installation and Verification Guide Software, Version 3.30r9. Recall #B-1408-8.

CODE
Product Code 936483, Versions 3.30r9, et.al.

MANUFACTURER
Sanguin International Inc., Hamden, Connecticut.

RECALLED BY
Ortho Diagnostic Systems, Inc., Raritan, New Jersey, by letter dated August 28, 1996. Firm-initiated recall complete.

DISTRIBUTION
California, Colorado, Florida, Illinois, Indiana, Kentucky, Michigan, North Carolina, New Jersey, Ohio, South Carolina, Tennessee, Utah, Virginia, Washington State, Arizona, Texas, Minnesota.

QUANTITY
108 units were distributed.

REASON
A design defect in the computer software can cause a calculation error, which can affect the cutoff value, resulting in false negative results for anti-HCV, anti-HBc, and anti-HBs.

PRODUCT
Red Blood Cells. Recall #B-1409-8.

CODE
Unit #21GC36019.

MANUFACTURER
American Red Cross Blood Services, Portland, Oregon.

RECALLED BY
Manufacturer, by telephone on June 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon.

QUANTITY
1 unit was distributed.

REASON
Blood product which was CMV positive was labeled CMV negative.

PRODUCT
Platelets, Pheresis. Recall #B-1410-8.

CODE
Unit #20GE00773.

MANUFACTURER
American Red Cross Blood Services, Boise, Idaho.

RECALLED BY
Manufacturer, by letter dated April 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Montana.

QUANTITY
1 unit.

REASON
Blood product which was not tested for CMV, was distributed labeled CMV negative.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1417/ 1418-8.

CODE
Unit #40GV13313.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by telephone on May 6, 1998, and by letter dated May 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan and California.

QUANTITY
1 unit of each component.

REASON
Blood products were distributed after the donor provided post donation information regarding exposure to Hepatitis C.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Plasma. Recall #B-1419/1421-8.

CODE
Unit #54KE33639.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated May 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland, District of Columbia.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of hepatitis.

PRODUCT
Granulocyte Apheresis. Recall #B-1422-8.

CODE
Unit #P17226.

MANUFACTURER
The Blood Center of Central Iowa, Des Moines, Iowa.

RECALLED BY
Manufacturer, by letter dated September 4, 1997. Firm-initiated recall complete.

DISTRIBUTION
Iowa.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
Red Blood Cells. Recall #B-1423-8.

CODE
Unit #28108-4318 and 28108-7074.

MANUFACTURER
United Blood Services, McAllen, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
2 units were distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-1425/1426-8.

CODE
Unit #6552305.

MANUFACTURER
New York Blood Services, New York, New York.

RECALLED BY
New York Blood Center, Inc. (NYBC), New York, New York, by telephone on November 5 & 7, 1997, and by letter dated November 12, 1997. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of Hepatitis A.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

PRODUCT
Red Blood Cells, Irradiated. Recall #B-1391-8.

CODE
Unit numbers: 20FK06168 and 20GM31911.

MANUFACTURER
American Red Cross, Boise, Idaho.

RECALLED BY
Manufacturer, by telephone on February 2, 1998, and by letter dated March 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Montana.

QUANTITY
2 units were distributed.

REASON
Blood products were stored at unacceptable temperatures.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1406/1407-8.

CODE
Unit numbers: a) 2969988; b) 2970009.

MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, Indiana.

RECALLED BY
Manufacturer, by telephone on May 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products tested initially reactive for antibody to the hepatitis B core antigen (anti-HBc), followed by negative duplicate retesting, were inadvertently retested, with one positive and one negative result.

PRODUCT
Red Blood Cells. Recall #B-1411-8.

CODE
Unit #20GM34093.

MANUFACTURER
American Red Cross Blood Services, Boise, Idaho.

RECALLED BY
Manufacturer, by telephone on April 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Montana.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

PRODUCT
Adapter and breathing circuits assembled with the adapter listed
below:
a) Airlife Intubation Adapter, 22 mm O.D./15 mm I.D. Both Ends;
b) Airlife Isothermal Breathing Circuit, Adult Respiratory
Circuit Heated,
c) Airlife Isothermal Breathing Circuit, Adult Respiratory
Circuit Non-Heated;
d) Procedure Based Delivery System Nebulizer Kits, Custom
Packaged by Allegiance Healthcare Corporation, McGaw Park, IL.
Recall #Z-716/719-8.
CODE
a) Catalog No. 001820, Lot Nos. Y7H0170, Y7J1131, Y7J1132, Y7K0778, Y7K0779, Y7L0962, Y7L0963, Y7N0280, Y7N0281, Y7P0395, Y7P0394, Y7S0121, Y8A0338, Y8A0339, Y8B0427, Y8B0428, Y8C1917, Y8C1918, Y8D0452, Y8D0453, Y8E0943; b) Catalog No. 6035-H08, lot No. 8D0569, Catalog No. 6462-H08, Lot Nos. Y8B1723, Y8C0902, Y8C0991, Y8C0995, Y8C0996, Y8C0999, Y8C1000, Y8C2108, Y8C2283, Y8D1108, Y8D2290, Y8D2475, Y8D2520, F7K71771, F7K69101, F7K66501, Catalog No. 6463-H08, Lot Nos. Y8B0923, Y8B1690, Y8B1691, Y8B1692, Y8B1693, Y8B1694, Y8C1866, Y8D1277, Y8D1278, Y8D1279, F7N87301, F7K71711, F7K63521, Catalog No. 7460-HS7, Lot No. Y8C0409, Y8C0424, and F7K68661, Catalog No. 7503-HS7, Lot Nos. Y8D0558, Y8D0565, Y8D0573, and F7K68651, Catalog No. 7529-HS7, Lot Nos. Y8C0410, Y8C0421, and F7K68461, Catalog No. 7566-HS7, Lot Nos. Y8C0278, F7L76461, and F7K65961; c) Catalog No. 6687-855, Lot Nos. Y8D0692, Y8D0717, Catalog No. 6914-855, Lot Nos. Y8D0580, Y8D0581, Y8D0584, and F7K68671, Catalog No. 10122-855, Lot Nos. Y8D1195; d) Module NMK71-5682, Mfr. Dates 11/12/97, 10/16/97, and 10/2/97, Module SPC57-MASK: Mfr. Dates 3/11/98, 4/8/98, 5/12/98, and 6/15/98, Module E1456925A, All Lot Numbers, Module MC51SENEBB, All Lot Numbers prior to 7/1/98, Module MC51SENEBD, All Lot Numbers prior to 7/1/98, Module ISO514900B, All Lot Numbers, Module RES90-NHHC, All Lot Numbers.

MANUFACTURER
Allegiance Healthcare Corporation, Riverside, California.

RECALLED BY
Allegiance Healthcare Corporation, McGaw Park, Illinois, by letter on July 24, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada.

QUANTITY
8,469 cases of adapters and 123 cases of custom breathing circuits were distributed.

REASON
The adapter may have a thin, plastic membrane in the center of it, with the potential for airflow obstruction.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

PRODUCT
Hewlett Packard (HP) M1193A Reusable Neonatal SpO2 Sensor - used with the HP OminCare CMS patient monitor, compact-configured monitors, HP CodeMaster defibrillators with an SpO2 option and Series 50XM Fetal Monitors (M1350B). The device provides continuous non-invasive measurement (via neonatal hand/foot) of arterial oxygen saturation with an HP patient monitor. Recall #Z-720-8.

CODE

HP M1193A with the following serial numbers: IN613 03281 to 03480
OR the following serial number prefixes:
IN616 XXXX     (XXXX=all sequence nos.)
IN619 XXXX, IN620 XXXX, IN627 XXXX, IN628 XXXX, IN629 XXXX,
IN630 XXXX, IN631 XXXX, IN632 XXXX, IN708 XXXX, IN720 XXXX,
IN730 XXXX.
MANUFACTURER
Hewlett Packard, Boeblingen, Germany.

RECALLED BY
Hewlett-Packard Company, Medical Products Group, Andover, Massachusetts, by letter on July 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
1,969 units were distributed.

REASON
The device may exhibit arterial oxygen saturation measurement outside of the specified accuracy after months of use. The red light emitting diode in the sensor may degrade over time and the sensor will no longer function giving either no reading or an intermittent/variable reading in cases where normally a continuous reading would be expected.

PRODUCT
Moulding Body Personal Electro-Sauna weight loss system. Recall #Z-721-8.

CODE
None.

MANUFACTURER
Belthermic, S.A., de C.V., Colona Del Valle, Mexico.

RECALLED BY
TV Store Corporation and Body Fitness Products, Inc., Miami, Florida, by letter on June 22, 1998. Firm-initiated recall ongoing. See also FDA press release P98-19, July 2, 1998.

DISTRIBUTION
Nationwide, Puerto Rico, Canada.

QUANTITY
Approximately 30,000 units.

REASON
The device fails to perform as intended and has the potential to become too hot, to burn, cause fires (no known injuries), and cause skin burns (1st and 2nd degree) to individuals.

END OF ENFORCEMENT REPORT FOR AUGUST 12, 1998.


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