FDA

Enforcement Report

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

CODE
SO3189A.

MANUFACTURER
Sunshine Biscuits, Inc., Sayreville, New Jersey.

RECALLED BY
Sunshine Biscuits, Inc., Elmhurst, Illinois, press release, Trade Notices and fax on October 8, 1998, and by E-mail on October 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Wisconsin, New York, New Jersey, Texas.

QUANTITY
4,357 cases (12 boxes per case) were distributed; firm estimated that 35 percent of product remained on market at time of recall initiation.

REASON
Product contains undeclared eggs and dairy ingredients.

 PRODUCT
Queso Fresco Fresh Cheese in foil wrap, net weight 14 ounces. Recall #F-020-9.

CODE
Z0333 (manufactured on 5/5/98).

MANUFACTURER
Peregrina Cheese Company, Brooklyn, New York.

RECALLED BY
Manufacturer, by visit on or about May 26, 1998, and by press release on May 26, 1998 issued by the New York State Department of Agriculture and Markets. Completed recall resulted from sample analysis and follow-up by the New York Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
Approximately 600 units.

REASON
Product was contaminated with Listeria monocytogenes.

PRODUCT
Big Y Fun-Filled Family Favorites Kiddie Mix, in 11 ounce cellophane bag. Recall #F-024-9.

CODE
All date codes.

MANUFACTURER
Everson Distributing Company, Inc., Chicopee, Massachusetts (repacker).

RECALLED BY
Big Y Foods, Inc., Springfield, Massachusetts, by letter on September 23, 1998, and by press release on September 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts and Connecticut.

QUANTITY
78 cases (12 bags per case) were distributed.

REASON
Some bags of the mixed candy contain a peanut butter candy that is not usually included in the product and the product's label does not declare the presence of peanuts.

CODE
All lots lacking the declaration of specific colors. 030999, 030699, 022799, 022699, 012299, 120298, 120498, 110498

MANUFACTURER
Ellsworth Ice Cream Inc., Saratoga Springs, New York.

RECALLED BY
Manufacturer, by telephone on August 19, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York and Pennsylvania.

QUANTITY
1,079 cases (6 boxes per case) were produced.

REASON
Product contained undeclared Yellow No. 6, Red No. 40 and Blue No. 1.

PRODUCT
Nuccio's Fig Cookies, in 16 ounce hard plastic clam shaped containers. Recall #F-014-9.

CODE
Various.

MANUFACTURER
Nuccio's Italian Bakery, Brooklyn, New York.

RECALLED BY
Manufacturer, by visit and telephone during the last week of August 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
160 packages were distributed.

REASON
Products contained undeclared Yellow No. 5, Yellow No. 6, Red No. 3, and Blue No. 1.PRODUCT
Way Fong Green Banana Cake, in 4 ounce cellophane bags. Recall #F-015-9.

CODE
None.

MANUFACTURER
Linh Ky Asian Foods Inc., East Toronto, Ontario, Canada (exporter).

RECALLED BY
Synlyco Ltd., Brooklyn, New York, by visit on or about June 18, 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
150 packages were distributed.

REASON
Product contained undeclared FD&C Yellow No. 5.

PRODUCT
Jubilee Carolina Cole Slaw, in 4.75 pound containers. Recall #F-022-9.

CODE
EXP date 1012 stamped on container. The product code is #177.

MANUFACTURER
Made-Rite Foods, Inc., Greensboro, North Carolina.

RECALLED BY
Manufacturer, by letter faxed on September 30, 1998. Completed recall resulted from sample analysis and follow-up by the North Carolina Department of Agriculture.

DISTRIBUTION
North Carolina and Virginia.

QUANTITY
578 containers were distributed.

REASON
Product may contain pieces of hard plastic.

PRODUCT
Reisman's Jumbo Cookie with Sprinkles in sealed cellophane package, net weight 2.5 ounces. Recall #F-023-9.

CODE
S None.

MANUFACTURER
Reisman Brothers Bakery, Inc., Brooklyn, New York.

RECALLED BY
Manufacturer, by letter on August 11, 1997, and by visits. Completed recall resulted from sample analysis and follow-up from the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York, New Jersey, Pennsylvania, Indiana.

QUANTITY
Approximately 33.5 cases were distributed.

REASON
Product contained undeclared Yellow No. 5, Yellow No. 6, Red No. 3, Red No. 40, and Blue No. 1.

CODE
NOV1698SLB20600 thru 0700 (on the can) and MAY1799SLA20600 thru 0700 (on the 12-pack carton).

MANUFACTURER
The Coca-Cola Bottling Company of St. Louis, Maryland Heights, Missouri.

RECALLED BY
Manufacturer. The sales centers were verbally notified on September 9, 1998, followed by electronic mail memorandum on September 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri and Illinois.

QUANTITY
Approximately 608 12-packs were distributed. Firm estimates none remains on the market.

REASON
Product labeled as root beer actually contain diet root beer.

PRODUCT
Sunnyside Farms Vanilla Light Ice Cream, in 1/2 gallon cartons. Recall #F-018-9.

CODE
All codes bearing the incorrect nutrition facts panel.

MANUFACTURER
MidValley Dairy, Turlock, California.

RECALLED BY
Manufacturer, by notice sent on September 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
California and Nevada.

QUANTITY
Approximately 60,450 1/2 gallon containers were distributed.

REASON
The nutrition facts panel incorrectly states the amount of sugars as 4 g/serving when in fact the product contains 14 g/serving.

 
Inwood:       60 mg:  NDC # 0258-3609-01
              80 mg:  NDC # 0258-3610-01
             120 mg:  NDC # 0258-3611-01.
             160 mg:  NDC # 0258-3612-01
Qualitest:    80 mg:  NDC 0603-5498-21, 
             120 mg:   NDC 0603-5499-21,
             160 mg:   NDC 0603-5500-21 
United Research Laboratories (URL)
             80 mg:  NDC 0677-1364-01;
            120 mg:  NDC 0677-1365-01; 
            160 mg:  NDC 0677-1366-01. 160 mg 
Zenith Goldline Laboratories: 
             60 mg:  NDC 0182-1926-01.
             80 mg:  NDC 0182-1927-01.
            120 mg:  NDC 0182-1928-01.
            160 mg:  NDC 0182-1929-01. 
Teva (Lemmon) Pharmaceuticals USA 
             60 mg:  NDC 0093-0691-01. 
             80 mg:  NDC 0093-0692-01. 
            120 mg:  NDC 0093-0693-01. 
            160 mg:  NDC 0093-0694-01. 
Geneva Pharmaceuticals, Inc.
            60 mg:  NDC 0781-2061-01. 
            80 mg:  NDC 0781-2062-01. 
           160 mg:  NDC 0781-2064-01. 
Brightstone Pharma Inc. 
            60 mg: NDC 62939-7112-1. 
            80 mg: NDC 62939-7122-1. 
           120 mg: NDC 62939-7132-1. 
           160 mg: NDC 62939-7142-1.   Recall
#D-006/009-9.

CODE
Lot numbers (Expiration dates):

 
60 mg (10 lots): 7J031 (3/99), 7J033 (3/99), 8A042 (3/99), 
                 7K014 (5/99), 7K015 (5/99), 7K016 (5/99),   
                 7K018 (1/99), 8A035 (1/99), 8A38 (1/99),    
                 8A040 (2/99).
80 mg (4 lots):  7F052 (9/99), 8A047 (1/99), 8A048 (2/99),
                 8A052 (11/99).
120 mg (4 lots): 7K027 (9/99), 8A053 (1/99), 8A054 (1/99),
                 8A055 (1/99).
160 mg (4 lots): 7J045 (9/99), 8A060 (1/99), 8A061 (1/99),
                 8A062 (2/99).

MANUFACTURER
Inwood Laboratories, In., a subsidiary of Forest Laboratories, Inc., Inwood, New York.

RECALLED BY
Manufacturer, by letter on October 6, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
The following number of bottles were distributed:

60 mg :  33, 812
80 mg :  74, 247
120 mg:  35, 004
160 mg:  16, 752.

REASON
Dissolution failure.

PRODUCT
Nitrostat Sublingual Tablets, (Nitroglycerin) USP, 0.4 mg (1/150 gr), Rx, in bottles of 25. NDC #0071-0570-13. Recall #D-010-9.

CODE
Lot #01317F EXP 1/99.

MANUFACTURER
Warner Lambert Company, Fajardo, Puerto Rico.

RECALLED BY
Parke Davis, Division of Warner Lambert Company, Morris Plain, New Jersey, by letter on October 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
24,616 units were distributed.

REASON
Subpotent (18 month stability test station).

CODE
Unit #12431-8543.

MANUFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 31, 1998, and by letter dated October 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Mexico and Switzerland.

QUANTITY
1 unit of each component was distributed

. REASON
Blood products were collected in a manner that compromises the sterility of the products.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Cryoprecipitate; d) Plasma (Cryo Poor); e) Fresh Frozen Plasma. Recall #B-081/085-9.

CODE
Unit numbers: a) 11FM19675, 11W38080; b) 11W38080; c) 11FM19675; d) 11FM19675; e) 11W38080.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on September 4, 1997, and by letter dated September 11, 1997. Firm-initiated recall complete.

DISTRIBUTION
Alabama, Connecticut, Missouri, New York, California.

QUANTITY
a) 2 units; b-e) 1 unit of each component was distributed.

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

PRODUCT
Red Blood Cells. Recall #B-086-9.

CODE
Unit #Z02388.

MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.

RECALLED BY
Manufacturer, by telephone on March 10, 1998, and by letter dated March 31, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who had no hemoglobin/hematocrit check recorded screening.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-088/089-9.

CODE
Unit #Z02355.

MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.

RECALLED BY
Manufacturer, by telephone and fax on March 10, 1998, and by letter dated March 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Iowa and Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor taking the drug Methotrexate.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-091/092-9.

CODE
Unit #V39358.

MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.

RECALLED BY
Manufacturer, by telephone on February 3, 1997, and by letter dated February 6, 1997, and Fax on February 5, 1997. Firm-initiated recall complete.

DISTRIBUTION
Virginia and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had sexual contact with someone who had lived in a HIV Group O risk area.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-093/094-9.

CODE
Unit numbers: a) 12X71842, 12X71847; b) 12X71842.

MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.

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

DISTRIBUTION
North Carolina.

QUANTITY
a) 2 units; b) 1 unit.

REASON
Blood products were mislabeled as CMV antibody negative.

PRODUCT
LRC Platelets, Pheresis. Recall #B-095-9.

CODE
Unit #12428-6903.

MANUFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on January 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Mexico.

QUANTITY
1 unit was distributed.

REASON
Platelets, Pheresis unit containing visible aggregates was inappropriately released from quarantine.

PRODUCT
Platelets, Pheresis. Recall #B-096-9.

CODE
Unit numbers: 10585-2689-01, 10585-2731-01, 10585-2731-02, 10585-2740-01, 10585-2740-02, 10585-2744-01, 10585-2744-02, 10586-4612-01, 10586-4612-02, 10585-2761, 10585-2752, 10585-2760.

MANUFACTURER
Blood Systems, Inc., Glendale, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated June 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Arizona.

QUANTITY
12 units were distributed.

REASON
Platelets, Pheresis were prepared using an instrument which had not been validated for sterility.

CODE
Unit #W77043.

MANUFACTURER
Healthcare Provider Services, Inc., doing business as Rhode Island Blood Center, Providence, Rhode Island.

RECALLED BY
Manufacturer, by telephone on February 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
1 unit was distributed.

REASON
Unlicensed blood product was distributed in interstate commerce.

PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated. Recall #B-087-9.

CODE
Unit #N39852.

MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.

RECALLED BY
Manufacturer, by telephone on October 28, 1997. Firm-initiated recall complete.

DISTRIBUTION
Iowa.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

CODE
Lot #757971011A.

MANUFACTURER
Althin Medical, Inc., Miami, Florida.

RECALLED BY
Manufacturer, by letter on June 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Japan.

QUANTITY
523 cases (12 units per case) were distributed.

REASON
Cracked blood ports may compromise the sterility barrier and may also cause blood leakage.

PRODUCT
a) Fukuda Denshi Model HS-500 Super Module, input module for the Model DS 5300 Patient Monitor. The DS-5300 Patient Monitor is indicated in those situations where observations of one or more of the following parameters on an individual patient may be required: ECG, respiration, non-invasive and/or invasive blood pressures, temperature, pulse oximetry and cardiac output. Catalog #HS-500 Super Module for DS-5300 Patient Monitor. DS-5300 Patient Monitor. b) Fukuda Denshi Model DS-5100E Patient Monitor is a pre-configured monitor indicated in those situations where observations of one or more of the following parameters on an individual patient may be required: ECG (waveform, heart rate, ST-level, and ventricular arrhythmias) respiration, non-invasive and/or invasive blood pressures, temperature, and pulse oximetry. The observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. It is indicated in situations where the patient may need to be monitored while being transported within the health care facility. Catalog #5100E Patient Monitor. Recall #Z-841/842-8.

CODE
All units are affected.

MANUFACTURER
a) Fukuda Denshi Co. LTD, Tokyo, Japan b) Fukuda Denshi USA Inc., Redmond, Washington.

RECALLED BY
Fukuda Denshi America Corp., Redmond, Washington, by letter dated August 20, 1998. Firm-initiated field correction complete.

DISTRIBUTION
a) Arizona, California, Florida, Indiana, Kentucky, Ohio, Pennsylvania, Texas; b) California, Florida, Illinois, Kentucky, Ohio, Texas, Japan.

QUANTITY
a) 109 units; b) 47 units were distributed.

REASON
Possible inaccurate non-invasive blood pressure measurements.

PRODUCT
Optional Servo-Controlled Humidifier for the Ohmeda Ohio Care Plus Incubator The device is used to provide an efficient supply of humidified air to help meet the patient's thermoregultory needs by reducing convective and evaporative heat loss. Recall #Z-872-8.

CODE
Humidifier Serial No. Range HCHY00001-HCHY00247, HCHZ00001-HCHZ00383, HCHA00001-HCHA00440, HCHB00001-HCHB00205. Used with the following devices: Care Plus Access 3000 (with Servo Humidifier option) Care Plus 4000 (with Servo Humidifier option) Care Plus Access 4000 (with Servo Humidifier option.

MANUFACTURER
Ohmeda Medical, Columbia, Maryland.

RECALLED BY
Manufacturer, by letter dated July 20, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide.

QUANTITY
887 units were distributed.

REASON
Failure of the heater foil on the servo-controlled humidifier heater that caused the humidifier lid to overheat and partially melt at the point of contact. The malfunction was caused by the humidifier heater foil becoming detached from the heat sink and touching the plastic lid.

PRODUCT
NPS/BPS/MPS Version 11.3 Low Dose Planning Software, used to plan low dose rate seed implantation positions for prostate brachytherapy. Recall #Z-873-8.

CODE
Model MPSV.11.3, Catalog #035.922.

MANUFACTURER
Nucletron BV, The Netherlands.

RECALLED BY
Nucletron Corporation, Columbia, Maryland, by technical bulletin on or about March 9, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide.

QUANTITY
19 units were distributed.

REASON
There is a flaw in the software coding in that the "Output of treatment set-up/times" does not include seeds if the preplanning box is extended.

PRODUCT
Manan Super-Core Biopsy Needle 18 ga X 15 cm, 20 ga X 15 cm, 18 ga X 9 cm, 16 ga X 20 cm, 16 ga X 15 cm, 14 ga X 9 cm, 20 ga X 20 cm and 18 ga X 20 cm., used to obtain soft tissue biopsies, such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen and lungs. Recall #Z-063-9.

CODE
All catalog numbers "VLT 14/9X" through "VLT 20/20X" and Lot Numbers 81391208 through 82182261 are involved in this field correction.

MANUFACTURER
Medical Device Technologies, Inc., Gainesville, Florida. RECALLED BY
Manufacturer, by letter on September 11, 1998, and October 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Tennessee, Texas, Florida, Indiana, Pennsylvania, New Jersey, Michigan, Massachusetts, New York, Illinois, Wisconsin, Washington state, Oregon, California, Arizona, Missouri, Kansas, Minnesota, Nevada, international.

QUANTITY
798 devices were distributed.

REASON
The clear plastic film of some of the device's pouch packaging may exhibit cuts thereby compromising the sterile barrier.

PRODUCT
Activa Tremor Control System implantable device is meant to suppress tremors in the upper extremity in patients with essential tremor or Parkinsonian tremor. Recall #Z-090/092-9.

CODE
All codes.

MANUFACTURER
Medtronic, Inc-Neurological Division, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, verbally in July 1998, and by letter on October 1, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 725 units were distributed as of 10/1/98.

REASON
Fractures of the lead when the lead/extension connector is placed in the neck rather than the head. These fractures can interfere with stimulation delivery.

PRODUCT
Max-I-Probe Periodontal/Endodontic Irrigating Probes, Cartridge Pak/Plastic Hub, 24G x 1", 0.022" O.D., Part No. MAXP241; 100 probes per box, a sterile, non-pyrogenic single use device used to irrigate gingival sulci, root canal preparations, and endosseous Implant preparations during dental procedures. Recall #Z-095-9.

CODE
Part number MAXP241, lot numbers 12902 and 12903, EXP 04/2003.

MANUFACTURER
DENTSPLY MPL Technologies Inc., Franklin Park, Illinois.

RECALLED BY
Manufacturer, by letter dated October 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Michigan, California, Virginia, Arkansas, Louisiana, Texas, Pennsylvania, Washington state, New York, Indiana, Nevada, Minnesota, South Carolina, Georgia, Connecticut, Wisconsin, Missouri, Oregon, New Jersey, Florida, Canada.

QUANTITY
586 boxes were distributed; firm estimated that 50 percent of the product remained on market at time of recall initiation.

REASON
The probes were found to contain bacterial endotoxin, although labeled as non-pyrogenic.

PRODUCT
a) I-125 Seeds, (Iodine-125) Therapeutic for Interstitial Brachytherapy, Model 6711, a welded titanium capsule containing radioactive Iodine-125 absorbed onto silver rod, used as radioactive implants for the treatment of prostate cancer; b) I-125 RAPID Strand, Rigid Absorbable Permanent Implant Device, I-125 Seeds for Brachytherapy, Model 7000, indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment, such as prostate cancer or unresectable tumors, or for treatment of residual disease after excision of the primary tumor. Recall #Z-112/113-9.

CODE
Model 6711 - lot W82167, Model 7000 - lot P8108B.

MANUFACTURER
Medi-Physics, Inc., Arlington Heights, Illinois.

RECALLED BY
Nycomed Amersham Imaging, Princeton, New Jersey, by telephone on September 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Massachusetts, Florida, Mississippi, Utah, Missouri and Wisconsin.

QUANTITY
307 seeds and 46 strands were distributed.

REASON
The seeds were mislabeled with an incorrect apparent radioactivity range.

PRODUCT
I-125 Seeds, (Iodine-125) Therapeutic for Interstitial Brachytherapy, Model 6711, a welded titanium capsule containing radioactive Iodine-125 absorbed onto silver rod, used as radioactive implants for the treatment of prostate cancer. Recall #Z-114-9.

CODE
Lot W82249.

MANUFACTURER
Medi-Physics, Inc., Arlington Heights, Illinois.

RECALLED BY
Nycomed Amersham Imaging, Princeton, New Jersey, by telephone on October 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
81 seeds were distributed.

REASON
The seeds were mislabeled with an incorrect apparent radioactivity range.

PRODUCT
Irrivac*Max Model 200-20 Double Spike Irrigation Aspiration Set with Probe, a sterile, single-use device designed for irrigation and aspiration during all minimally invasive surgical procedures. Recall #Z-115-9.

CODE
Lots 50901762, 40901770, 50901781, 50901800, 50901860.

MANUFACTURER
Dexide, Inc., Fort Worth, Texas.

RECALLED BY
Manufacturer, by telephone and/fax on August 19, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
543 cases (5 units per case) were distributed.

REASON
During a rework procedure to replace the label, the seal of the outer bag (the product is double bagged) was penetrated which may compromise the sterility of the device.

a: Code 31679 - 16FR Suction Catheter with SAFE-T-VAC VALVE, 2
Walleted Latex Gloves, pop-up solution cup; 
b) Code 37025 - 10FR Suction Catheter with REGU-VAC Valve, two
(2) Latex Gloves, Pop-up solution cup; 
c) Code 37224 - 12 Fr Suction Catheter with SAFE-T-VAC VALVE, 2
Vinyl Gloves, pop-up solution cup;
d) Code 36630 - 6FR Graduated Suction Catheter with REGU-VAC 
Valve two (2) Latex Gloves, Pop-up solution cup
e) Code 36830 - 8 FR Graduated Suction Catheter with REGU-VAC
VALVE,( 2) latex gloves, pop-up solution cup; 
f) Code 33800 - 18FR (Coil packed) Suction Catheters with 
SENS-VAC loop packed valves;
g) Code 36114 - 14FR Suction Catheter with REGU-VAC VALVE, 2
vinyl gloves, pop-up solution cup, foil pouch of sterile saline;
h) Code 36688 - 6FR Suction Catheter with SAFE-T-VAC VALVE, one
latex glove, pop-up solution cup;
I) Code 30690 - 6FR graduated, DeLee Suction Catheters with SENS-
VAC loop packed valves.  Recall #Z-722/730-8.

CODE
Lot numbers: a) BD1709KG; b) ED0118KG; c) ED2835KG; d) FD3613KG; e) FD3713KG, FD3813KG, FD3913KG, FD4013KG, HD2613KG, LD1513KG f) BD5308KG; g) DD4111KG; h) FD4213KG; I) KD0514KG, LD0814KG.

MANUFACTURER
Kendall Healthcare Products Company, Especialidades Medicas Kenmex, Mexico.

RECALLED BY
Kendall Healthcare Products Company, Mansfield, Massachusetts, by letter on July 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
a) 210 cases; b) 300 cases; c) 300 cases; d) 280 cases; e) 1,223 cases; f) 336 cases; g) 180 cases; h) 140 cases; I) 64 cases were distributed.

REASON
Mislabeled - Incorrect French size.

PRODUCT
Braemar Arrhythmia Event Monitors, Models ER710 and ER720, patient-activated ambulatory event monitors used to record infrequent and elusive heart arrhythmias. Recall #Z-116/117-9.

CODE
Serial numbers between 1000001 and 1000146.

MANUFACTURER
Braemar, Inc., Burnsville, Minnesota.

RECALLED BY
Manufacturer, by "Braemar Product Tech Tip" dated August 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Georgia, Illinois, Missouri, New Jersey, South Carolina, Virginia, Washington state, Argentina, Belgium, Israel.

QUANTITY
60 units were distributed.

REASON
A component (capacitor) in the LCD circuitry was installed with the incorrect polarity. This could cause intermittent dark stripes on the liquid crystal display (LCD) or, if the capacitor fails, cause a permanently blank display.

a) Fermenta Animal Health Atgard (Dichlorvos) Swine Wormer - l.91
oz, 0.40 oz Pouches
b) Cutter Dichlorvos Horse Wormer - 2.75 oz Pouches
Recall #V-003/004-9.
CODE

Atgard 0.04 oz.:  115AY02, 026AY01, 096AY04, 017AY02, 037AY03
       1.92 oz.:  085AY01, 115AY02, 026AY01, 066AY02, 096AY04,
       017AY01, 017AY02;
Cutter Dichlorvos Horse Wormer:  074AH01, 074AH02, 065AH01, 
036AH01.

MANUFACTURER
Boehringer Ingelheim Animal Health, Inc., Elwood, Kansas.

RECALLED BY
Boehringer Ingelheim Vetmedica, Inc. St. Joseph, Missouri, by letter dated July 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
a) Nationwide; b) Kansas.

QUANTITY
a) 266,554 pouches; b) 49,704 pouches were distributed.

REASON
Products failed routine stability testing.