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.

July 15, 1998
98-28

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

PRODUCT
American's Choice brand Jumbo Ring Creme Cake, 2 flavors: a) America's Choice brand Jumbo Chocolate Creme Ring Cake; b) America's Choice brand Jumbo Lemon Creme Ring Cake. Recall #F-244/245-8.

CODE
All with sell-by date prior to 11/12/97.

MANUFACTURER
Kohl's Food Stores, Division of A&P Tea Company, Inc., doing business as Kohl's Bakery & Deli Kitchens, Milwaukee, Wisconsin.

RECALLED BY
Manufacturer, by telephone on November 8, 1997. Firm-initiated recall complete.

DISTRIBUTION
Wisconsin.

QUANTITY
600 cakes were for sale. All were relabeled with corrected labels.

REASON
Product contained undeclared eggs.

PRODUCT
Safeway Select Pralines'N Cream Light Ice Cream, in half gallon containers. Recall #F-537-8.

CODE
All codes.

MANUFACTURER
Bellevue Ice Cream, Bellevue, Washington; Capitol Heights Ice Cream, Capitol Heights, Maryland, and Von's, Los Angeles, California.

RECALLED BY
Safeway, Inc., Pleasanton, California, by E-mail and telephone on May 19, 1998, and by press release on May 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
Alaska, Washington state, Oregon, Idaho, Montana, California, Nevada, Hawaii, Maryland, and District of Columbia.

QUANTITY
1,512 cases containing six 1/2 gallon containers were distributed.

REASON
Product contains undeclared pecans.

PRODUCT
Duncan Hines Chewy Fudge Brownie Mix, family size, packed in 21 ounce (1 pound 5 ounce) 595 gram cardboard retail packages. Recall #F-538-8.

CODE
8112M5

MANUFACTURER
Olmarc Packaging Corporation, North Lake, Illinois.

RECALLED BY
Aurora Foods, Inc.,Columbus, Ohio, by letter, press release and notified the Food Allergy Network on May 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
8,942 cases (107,304 retail packages) were distributed.

REASON
Product contains undeclared walnuts.

PRODUCT
La Martinique Blue Cheese Vinaigrette Restaurant Dressing, in 8 fluid ounce (236 ml) containers. Recall #F-540-8.

CODE
"AUG 16 99".

MANUFACTURER
Reily Foods/Blue Plate Foods, New Orleans, Louisiana.

RECALLED BY
Reily Foods Company, Inc., New Orleans, Louisiana, by letter sent on April 14, 1998, and by press release on April 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
2,805 cases (12 units per case) were distributed.

REASON
Product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

PRODUCT
ConAgra Rye Meal Pumpernickel Flour, in 50 pound bags. Recall #F-539-8.

CODE
HA04098.

MANUFACTURER
ConAgra, Inc., Hastings, Minnesota.

RECALLED BY
ConAgra Flour Milling Company, Omaha, Nebraska, by telephone on April 23, 1998, and June 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Colorado, Maryland, New Jersey, New York, Ohio.

QUANTITY
182 50-pound bags were distributed.

REASON
Product contains undeclared wheat flour.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

PRODUCT
Oxygen, Medical, USP, Compressed, in high pressure E cylinders, Rx. Recall #D-182-8.

CODE
Lot numbers: 42001A and 42001B.

MANUFACTURER
Sieps Homecare, Inc., doing business as Family Homecare, Rock Rapids, Iowa.

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

DISTRIBUTION
Minnesota.

QUANTITY
2 cylinders were distributed.

REASON
Subpotent and good manufacturing practice deviations.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

PRODUCT
Compressed Oxygen USP, Transfilled in E and M6 size aluminum cylinders. Recall #D-172-8.

CODE
E-size aluminum cylinders with lot # sticker as follows: 04259803-3 units; 01139801-3 units; 01139802-3 units; 01139803-3 units; 01139804-3 units; 01139805-3 units; 01229803-3 units; 01229806-3 units; 01229807-3 units; 01229808-3 units; 01159801-3 units; 01159802-3 units; 01159803-3 units; 01159804-3 units; 01159805-3 units; 01159806-3 units; 01159808-3 units; 01159809-3 units; 01059801-3 units; 01059802-3 units; 01059803-3 units; 01059804-3 units; 01059805-3 units; 01059806-3 units; 01059807-3 units; 12299701-3 units; 12299702-3 units; 12299703-3 units; 12299704-3 units; 10149702-3 units; 10109702-3 units; 10109703-3 units; 10109705-3 units; 10109706-3 units; 10109707-3 units; 10109708-3 units; 10089701-3 units; 10089702-3 units; 10089704-3 units; 10089708-3 units; 10069701-3 units; 10069702-2 units; 10069703-3 units; 10069705-3 units; 10039701-3 units; 10039704-3 units; 10039705-3 units; 10019704-3 units; 10019705-3 units; 10019706-3 units; 09309701-3 units; 09309702-3 units; 09309707-3 units; 09309708-3 units; 09309709-3 units; 09309711-3 units; 09199701-3 units; 09199702-3 units; 09199704-3 units; 09179701-3 units; 09179707-3 units; 09179708-3 units; 09179709-3 units; 08139701-3 units; 08129701-3 units; 08129702-3 units; 08129703-3 units; 08129704-3 units; 08129705-3 units; 08129706-3 units; 08059702-3 units; 08059703-3 units; 08059705-3 units

M6-size aluminum cylinders with lot # sticker as follows: 02279808-3 units; 01229801-3 units; 01229802-3 units; 01229804-3 units; 01229805-3 units; 01159807-3 units; 01029801-3 units; 01029802-3 units; 12299705-3 units; 12299706-3 units; 10109701-3 units; 10109704-2 units; 10109709-3 units; 10089703-1 unit; 10089705-3 units; 10089706-3 units; 10089707-1 unit; 10089709-3 units; 10069704-3 units; 10069706-3 units; 10039702-3 units; 10039703-3 units; 10039706-3 units; 10039707-3 units; 10039708-1 unit; 10019701-3 units; 10019702-3 units; 10019703-3 units; 09309703-3 units; 09309704-3 units; 09309705-3 units; 09309706-3 units; 09309710-3 units; 09309712-3 units; 09199703-3 units; 09179702-3 units; 09179703-3 units; 09179704-3 units; 09179705-3 units; 09179706-3 units; 08139702-3 units; 08139703-3 units; 08059701-3 units; 08059704-3 units

MANUFACTURER
Shiv Respiratory Equipment, Inc., doing business as American Respiratory Equipment, Inc., Latham, New York.

RECALLED BY
Manufacturer, by memorandum dated May 17, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York.

QUANTITY
218 E-size cylinders; 125 M6-size cylinders were distributed.

REASON
Subpotency.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

UPDATE
SureStep Consumer Blood Glucose Meters (LifeScan, Milpitas, California), Recall #Z-631-8, which appeared in the July 1, 1998 Enforcement Report should read: CODE: All Models, Serials #'s: L6000 XX XXXXX through L7205 XX XXXXX and L7206 GA 00001 through L7206 GA 01128

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

PRODUCT

Ohmeda Tec 6 Desflurane Vaporizers (Note: Excludes North American
Drager (NAD) and Dragerwerk Tec 6 Variant Vaporizers).
Potentially affected vaporizers would include:
     Model                             Part Number
Tec 6 120v-USA                        1107-9001-000
Tec 6 120v-Canada                     1107-9012-000
Tec 6 120v-France                     1107-9003-000
Tec 6 220/240v-England                1107-9002-000
Tec 6 220/240v-Germany                1107-9004-000
Tec 6 220/240v-Italy                  1107-9005-000
Tec 6 220/240v-Dutch                  1107-9006-000
Tec 6 220/240v-Sweden                 1107-9007-000
Tec 6 220/240v-Spain                  1107-9008-000
Tec 6 220/240v-Finland                1107-9009-000
Tec 6 220/240v-Norway                 1107-9010-000
Tec 6 220/240v-Danish                 1107-9011-000
Tec 6 220/240v-England-Europe         1107-9014-000
Vaporizers are desflurane anaesthetic vaporizers used on Ohmeda
Anesthesia Systems, including:  Ohmeda Excel 110, 210, and 210SE;
Ohmeda Modulus II and Modulus II Plus; Ohmeda Modulus SE; Ohmeda
Modulus CD.  Recall #Z-642-8.

CODE
Vaporizers serviced by Datex-Ohmeda from 7/11/97 to 4/14/98. Subject Tec 6 Vaporizers have individual serial numbers which are not sequential.

MANUFACTURER
Datex-Ohmeda (formerly Ohmeda Medical Systems Division), Madison, Wisconsin.

RECALLED BY
Manufacturer, by letter on June 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
6,207 vaporizers were distributed.

REASON
Gas leaks.

PRODUCT
a) 3M Modular Shoulder System, 14 mm X 125 mm stems, product number 17464; b) 3M Modular Should System, 16 mm X 125 mm stems, product number 17466, a metal stem designed to fit into a surgically-prepared cavity in a humerus bone during shoulder joint replacement surgery. The stems are designed for "press-fit applications", but may also be cemented. Recall #Z-643/644-8

CODE
Lot numbers: a) 96 G 398; b) 96 G 348.

MANUFACTURER
3M Health Care, Rotherham, England.

RECALLED BY
3M Health Care, St. Paul, Minnesota, by letter dated June 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 42 stems; b) 31 stems were distributed.

REASON
One stem with a 16 mm diameter was in a box labeled as 14 mm diameter.

PRODUCT
Medex Injection Adapter, with Male Leur Lock, intended for use in the administration of small volume fluids, using syringes. Recall #Z-645-8.

CODE
Catalog #MX492, Lot #27L011175.

MANUFACTURER
Medex, Inc., Dublin, Ohio (packager).

RECALLED BY
Medex, Inc., Hillard, Ohio, by letter on June 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Arkansas, Illinois, New Jersey, Pennsylvania, New York, Montana, Connecticut, California, Maryland, Missouri, North Carolina, Tennessee, Texas, Virginia, Iowa, Oregon, Minnesota.

QUANTITY
390 cases (100 units per case) were distributed.

REASON
The sterility of the device cannot be assured due to defective packaging.

PRODUCT
Newport Infant/Adult "Breeze" Ventilator, designed for respiratory support of infants, pediatrics, or adults: a) Model E200D (domestic sales) Ventilator; b) Model E200E (foreign sales) Ventilators. Recall #Z-646/647-8.

CODE
The serial numbers of the 61 ventilators under recall are as follows: 9704WD143; 9704WD147; 9709WD312; 9711WE396 through 9711WE415; 9712WE416; 9712WE418; 9712WE421 through 9712WE430; 9712WE432; 9712WE433; 9712WE435 through 9712WE437; 9712WE439 through 9712WE441; 9712WE443; 9712WE444; 9712WE446 through 9712WE449; 9712WE451; 9712WE452; 9712WE454; 9801WE001 through 9801WE003; 9801WE005 through 9801WE007; 9801WE023; 9801WE026; 9802WE032; 9802WE038.

MANUFACTURER
Mer-Mar, Inc., Hesperia, California (PC Board); Harris Central Application, Palm Bay, Florida (chip).

RECALLED BY
Newport Medical Instruments, Inc., (NMI) Costa Mesa, California, by letter on March 5, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
61 ventilators were distributed.

REASON
A bad IC (chip) causes inadvertent System Reset, continually during power-up, or randomly during operation, wherein (1) the ventilators cease operation (gas flow ceases and the exhalation valve opens) for about 4 seconds, then restarts at values that were set before the reset (except as follows), (2) the Sigh Function defaults to off, (3) the Nebulizer defaults to off, (4) the Inspiratory Minute Volume Alarm defaults to the 0-50 L. range (an increase by a factor of 10 if originally set in the 1-5 L. range), (5) Apnea Back-up Ventilation will likely commence for foreign units (at 1.5 times the set rate, but with a minimum of 15 breaths/min and a maximum of 100 breaths/min with previously set tidal volumes and pressures), and (6) the low pressure alarm will likely reset, leading to nuisance alarms.

PRODUCT
Victoreen VeriDose Diodes, designed for use as radiation detection devices encased within a polystyrene material: a) Model 30-472 positive polarity VeriDose diodes; b) Model 30-472-8000 negative polarity VeriDose Diodes. Recall #Z-649/650-8.

CODE
All serial numbers manufactured since August 1997.

MANUFACTURER
Victoreen, Inc., Cleveland, Ohio.

RECALLED BY
Manufacturer, by telephone on May 7, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Arizona, Kentucky, New York, Pennsylvania, Florida, Virginia, Maryland, Michigan, Wisconsin, Ohio, Tennessee, Texas, Alabama, Georgia, Mississippi.

QUANTITY
23 diodes were distributed.

REASON
The devices were manufactured with an inappropriate shielding material (build-up cap). The diodes are intended for use at energies of 5 to 11 MV, while the build-up caps are intended for use in diodes for energies of 1 to 4 MV.

PRODUCT
Tracheal Intubation Fiberscope Instruction Manual: a) Catalog No. 8080201, LF-P Instruction Manual; b) Catalog No. 8080202, LF-2 Instruction Manual. Recall #Z-667/668-8.

CODE
Incorrect Manual Labeling Identification Numbers: Serial numbers of affected units: a) 1700832 1700833 1700840 1810903 1700844 1700851 1700828 1700855 1700827 1700831 1810900 1700841 1700856 1700857 b) 2715299 2715184 2715296 2715277 2815337 2815313 2715179 2815381 2815406 2715281 2815419 2715173 2715170 2715235 2715242 2715258 2715265 2715304 2815420 2815422 2815423 2715260 2715266 2715269 2715270 2715172 2715214 2825457 2815317 2715252 2715233 2715234 2715245 2815325 2815442 2715202 2715232 2815412 2815438 2815371 2815414 2815348 2815353 2815417 2815360 2815355 2715272 2715291 2715186 2815413 2715271 2715221 2815408 2715308 2715294 2715192 2715209 2715286 2825468 2815362 2815370 2715162 2715178 2715185 2815350 2815364 2715241 2815349 2815384 2715158 2715163 2715204 2815345 2715177 2815380 2715227 2815319 2715276 2715279 2815389 2815398 2815396 2815418 2715297 2815339 2715169 2715231 2715191 2815378 2715180 2715287 2715273 2715290 2715152 2815410 2815309 2815344 2715298 2815436 2825326 2815376 2715292 2815328 2815315 2815405 2715217 2715155 2715164 2715278 2815386 2815363 2815428 2715189 2715244 2715239 2815414 2815359 2815335 2815427 2715267 2715284 2715240 2815349 2715167 2715183 2715230 2715237 2715274 2715157 2825454 2815352 2815377 2825466 2715205 2815415 2715254 2715226 2825452 2715302 2715196 2715181 2715176 2815340 2815356 2815327 2715171 2715215 2815387 2815404 2715289 2715301 2715238 2715187 2815416 2815388 2815367 2715282 2715293 2815409 2715280 2815347 2715307 2715211 2815382 2715168 2815383 2815401 2715199 2715198 2715220 2815421 2715300 2715288.

MANUFACTURER
Olympus Optical Company, Ltd., Hinode Plant, Tokyo, Japan and Olympus Opto-Electronics Company, Ltd., Fufushima-ken, Japan.

RECALLED BY
Olympus American, Inc., Melville, New York (distributor), by letter on or about June 3, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 27 units; b) 287 units were distributed were distributed.

REASON
The cover pages for the instruction manuals were for the correct intubation fiberscope, but the rest of the instructions were for the other one.

PRODUCT
Model Tru-Pulse C02 Laser System, used in general surgery. Recall #Z-669-8.

CODE
Model True-Pulse C02.

MANUFACTURER
Tissue Medical Lasers, Inc., Albuquerque, New Mexico.

RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan on July 1, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
275 units were distributed.

REASON
Noncompliance with performance standards for laser products in that the operators manual lacked calibration procedures.

PRODUCT
I-125 Seeds, (Iodine-125) Therapeutic for Interstitial Brachytherapy, Model 6711, used as radioactive implants for the treatment of prostate cancer. Recall #Z-670-8.

CODE
Lot W71536.

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

RECALLED BY
Manufacturer, by telephone on September 23, 1997. Firm-initiated recall complete.

DISTRIBUTION
Georgia and Florida.

QUANTITY
26 seeds 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, used as radioactive implants for the treatment of prostate cancer. Recall #Z-671-8.

CODE
Lot W72531.

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

RECALLED BY
Manufacturer, by telephone on January 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state, California, New York.

QUANTITY
161 seeds were distributed.

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

PRODUCT
Disposable Manual Resuscitator, Part #DMR2, used to deliver supplemental oxygen. Recall #Z-672-8.

CODE
None. Units shipped between January 28, 1998 and April 22, 1998.

MANUFACTURER
Nellcor Mexico, Tijuana, Mexico.

RECALLED BY
Nellcor Puritan Bennett, Carlsbad, California, by letter on May 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Italy.

QUANTITY
67,490 units were distributed.

REASON
The duckbill valve can become unseated, allowing rebreathing and/or insufficient inspiratory air pressure; and (2) the pressure relief valve ball can rust, causing it to become inoperative.

END OF ENFORCEMENT REPORT FOR JULY 15, 1998. BLANK PAGES MAY FOLLOW.

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