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
07/02/1991
FDA Enforcement for the week of 7/3/91
FDA ENFORCEMENT REPORT
FOR MAY 20, 1988
July 3, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
Product: Southern Belle brand Ready to Eat Roast Beef Sandwiches,
3.5 ounces. Recall #F-441-1.
Code: Pull date coded C8 through C29.
Manufacturer: Southern Belle Sandwich Company, Inc., Baton Rouge,
Louisiana.
Recalled by: Manufacturer, by oral communication March 19, 1991.
Firm-initiated recall ongoing.
Distribution: Louisiana, Florida, Mississippi, Alabama.
Quantity: Approximately 8,057 sandwiches were distributed; firm
estimates none remains on the market.
Reason: Product is contaminated with Listeria monocytogenes.
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Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Light n' Lively 100 Calorie Blueberry Nonfat Yogurt with
Aspartame Sweetener, in 8 ounce plastic cups.
Recall #F-438-1.
Code: Code date MAY 20.
Manufacturer: Kraft Inc., Dairy Group, Atlanta, Georgia.
Recalled by: Kraft General Foods, Glenview, Illinois, by issuing an
inner-office communication on May 10, 1991 and by
telephone May 11, 1991 and by visit May 15, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1960 cases (12 cups/case) were distributed; firm estimates
115 cases remain on the market.
Reason: Product is contaminated with yeast and mold.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: SDM 17 (Bulk Drug: 10% Nitroglycerin on Lactose, U.S.P.),
net weights of either 200 pounds or 152 pounds per drum.
Recall #D-421-1.
Code: Lot numbers: G17-36, J17-6, G17-40, J17-8 THRU J17-13,
G17-42 THRU G17-49, J17-15 THRU J17-17, G17-56 THRU G17-58,
J17-20 THRU J17-33, G17-60 THRU G17-70, G17-75, G17-77,
G17-80, G17-81, G17-91, G17-145 THRU G17-148.
There is no expiration date on the product.
Manufacturer: Atlas Powder Company, Tamaqua, Pennsylvania.
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Recalled by: ICI Americas, Inc., Wilmington, Delaware, by telephone
between September 27, 1988 and October 6, 1988 followed by
visit. Firm-initiated recall ongoing.
Distribution: New York, New Jersey, Colorado, Illinois, Indiana, Missouri,
Massachusetts, Pennsylvania, Canada, Puerto Rico.
Quantity: 509,436 pounds were distributed.
Reason: Subpotency.
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Product: Source Plasma. Recall #B-302-1.
Code: Unit numbers: 5617, 5643, 5652, 5654, 5658, 5664, 5670,
5672, 5677, 5681, 5682, 5690, 5691, 5695, 5698, 5701, 5702,
5703, 5708, 5709, 5713, 5714, 5717, 5720, 5721, 5726, 5727,
5732, 5733, 5735, 5739, 5740, 5741, 5745, 5752, 5753, 5755,
5758, 5759, 5760, 5766, 5770, 5771, 5772, 5777, 5779, 5784,
5785, 5786, 5790, 5794, 5796, 5797, 5800, 5805, 5806, 5808,
5813, 5817, 5820, 5821, 5823, 5826, 5834, 5835, 5837, 5840,
5844, 5845, 5847, 5848, 5854, 5856, 5859, 5866, 5872, 5874,
5878, 5882, 5884, 5893, 5894, 5898, 5903, 5904, 5905, 5914,
5915.
Manufacturer: The Laboratory of Denver, Inc., Aurora, Colorado.
Recalled by: Manufacturer, by telephone and by letter March 13, 1991,
Firm-initiated recall complete.
Distribution: Florida, Canada, Sweden.
Quantity: 88 units.
Reason: Blood products collected from donors who were immunized
with red blood cells from donors participating in high
risk behavior, were distributed.
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Product: (a) Whole Blood; (b) Red Blood Cells;
(c) Platelets; (d) Cryoprecipitated AHF;
(e) Recovered Plasma. Recall #B-309/313-1.
Code: Unit numbers: (a) 12KJ41956; (b) 12G74256, 12FM25803,
12KC44949, 12KK39914, 12KK41279, 12L63778;
(c) 12FM25803, 12KK41279; (d) 12FM25803, 12KK41279;
(e) 12G74256, 12FM25803, 12KC44949, 12KK39914, 12KK41279,
12L63778.
Manufacturer: American Red Cross, Charlotte, North Carolina.
Recalled by: Manufacturer, by letters of August 28 and 30, 1990,
November 19, 1990, October 30, 1990 and by telephone
October 10, 1990 and November 13, 1990. Firm-initiated
recall ongoing.
Distribution: North Carolina, Illinois, California.
Quantity: (a) 1 unit; (b) 6 units; (c) 2 units; (d) 2 units;
(e) 6 units.
Reason: Blood products collected from donors who: 1)
emigrated from an area deemed high risk for human
immunodeficiency virus type-1 (HIV-1); 2) had
been recently tattooed; 3) had a history of childhood
jaundice; 4) had a history of cancer, were distributed.
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Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-319/322-1.
Code: Unit numbers: (a) 21F78128, 21F89686, 21S22161, 21S32429,
21S39330, 21H65933, 21K89904, 21H89450, 21G80449, 21M59452,
21J84418;
(b) 21F78128, 21S22161, 21S32429, 21K89904, 21H89450,
21G80449, and 21M59452;
(c) 21F78128, 21S22161, 21F89686, 21S32429, 21G80449,
21J84418;
(d) 21S22161, 21H65933, 21M59761, 21K89904, 21H89450,
21M59452.
Manufacturer: American Red Cross Blood Services, Portland, Oregon.
Recalled by: Manufacturer, by letters of March 22 and 29, 1991. Firm-
initiated recall ongoing.
Distribution: Washington state, Oregon, California, Nebraska.
Quantity: 30 components were distributed.
Reason: Blood components, collected from donors who 1)
participated in high risk behavior, 2) had a history of
hepatitis, or 3) were deferred due to previous hepatitis
testing results, were distributed.
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CLARIFICATION Recall #D-295-1, Diphenhydramine Hydrochloride Capsules,
NOTE: 50 mg, which appeared in the April 17, 1991 Enforcement
Report is limited to the Schein label.
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Class III -
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-290/293-1.
Code: Unit numbers: (a) 0181180 0181181 0181182 0181183
0181184 0181205 0181206 0181207 0181208, 0181209,
0181210, 0186457, 0186460, 0186462, 0186463, 0186464,
0186465, 0186466, 0186471, 0186472, 01861473, 0186551,
0186552, 0186553, 0186555, 0186556, 0186557, 0186558,
0186559, 0186560, 0186561, 0186562, 0186564, 0186567,
0186568, 0186570, 0186571, 0186573, 0186574, 0186721,
0186723, 0186724, 0186725, 0186726, 0186747, 0186748,
0186855, 0186856, 0186858, 0186859, 0186860, 0186862,
0186863, 0186866 through, 0186878, 0186900, 0186901
through, 0186915, 0186917 through 0186924, 0186943 through
0186959, 0186961 through 0186964, 0187052, 0187053,
0187054, 0187055, 0187061, 0187062, 0187064 through
0187071, 0187073, 0187075, 0187176, 0187180 through
0187186, 0187189, 0187190, 0187191, 0187192, 0187194,
0187247 through 0187263, 0187265, 0187266, 0187268,
0187269, 0187314, 0187317, 0187320, 0187327, 0187329
through 0187334, 0187338, 0187340, 0187427, 0187428,
0187429, 0187430, 0187432, 0187433, 0187436, 0187437,
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0187438, 0187439, 0187442, 0187451 through 0187455,
0187457, 0187458, 0187460, 0187461, 0187462, 0187529 through
0187536, 0187538, 0187539, 0187541, 0187542, 0187543,
0187544, 0187546, 0187548, 0187568, 0187600, 0187601,
0187602, 0187604 through 0187613, 0187615, 0187618, 0187619,
0187650, 0187652 through 0187656, 0187658, 0187971, 0187972,
0187973.
(b) 0186466, 0186467, 0186468, 0186469, 0186473, 0186567,
0186570, 0186571, 0186855, 0186859, 0186867, 0186869,
0186871, 0186903, 0186905, 0186907 through 0186910, 0186912,
0186917 through 0186921, 0186923, 0186924, 0187314, 0187317,
0187319, 0187326 through 0187332, 0187334, 0187338, 0187340,
0187455, 0187541, 0187546, 0187548, 0187568, 0187601,
0187602, 0187605, 0187607 through 0187613, 0187615, 0187651
through 0187655.
(c) 0186859, 0186923, 0187532.
(d) 0181180, 0181181, 0181182, 0181183, 0181184,
0186552, 0186553, 0186555 through 0186562, 0186564,
0186567, 0186568, 0186861, 0186866, 0186868, 0186872,
0186873, 0186874, 0186877, 0186901, 0186902, 0186904,
0186962, 0187537, 0187616, 0187617.
Manufacturer: Community Blood Center of Louisiana, Baton Rouge, Louisiana.
Recalled by: Manufacturer, by telephone February 6-8, 1991. Firm-
initiated recall complete.
Distribution: Florida, Illinois, Missouri, Louisiana.
Quantity: (a) 237 units; (b) 61 units; (c) 3 units; (d) 32 units.
Reason: Blood products incorrectly tested for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1 and the
antibody to the hepatitis C virus (anti-HCV), were
distributed.
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Product: Red Blood Cells. Recall #B-323-1.
Code: Unit #KC80566.
Manufacturer: Lifeblood/Mid-South Regional Blood Center, Memphis,
Tennessee.
Recalled by: Manufacturer, by telephone February 4, 1991. Firm-
initiated recall complete.
Distribution: Tennessee.
Quantity: 1 unit.
Reason: Blood product that tested positive for syphilis was
distributed.
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
Product: Ohmeda Logic 07 Ventilators, Non-rebreathing valves and
Black Rubber Membranes, Part No. 6750-0009-200.
Recall #Z-794/796-1.
-5-
Code: Serial numbers: Undetermined.
Manufacturer: Ohmeda, Madison, Wisconsin.
Recalled by: Manufacturer, by letter April 29, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: (a) 1,129; (b) -8,180; (c) 1,191 units were distributed.
Reason: The Black membrane used in the rebreathing valve was
manufactured improperly by the vendor. The membrane could
dislodge from its seat during ventilation. This could
cause either inadequate ventilation or aspiration of the
membrane.
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Class II -
Product: Promotional brochure entitled "Luque I.S.F. Interpeduncular
Segmental Fixation". Recall #Z-765-1.
Code: All promotional brochures which promoted use of the devices
for an unapproved use. No codes appear on the brochures
or price lists. (The devices are not subject to recall.)
Manufacturer: Danek Medical, Inc., Memphis, Tennessee.
Recalled by: Manufacturer, by letter June 1, 1990. Firm-initiated
field correction complete.
Distribution: Nationwide.
Quantity: Approximately 1,800 brochures were distributed.
Reason: The firm was promoting the device for posterior
attachment without an approved Premarket Approval
Application (PMA) or Investigational Device Exemption (IDE).
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Product: GasVue TGX-5 with 700m Laser Imaging System.
Recall #Z-766-1.
Code: Serial numbers: None.
Manufacturer: Laser Imaging Systems, Punta Gorda, Florida.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan June 10, 1991. Firm-initiated field
correction ongoing.
Distribution: Texas.
Quantity: 1 unit.
Reason: Noncompliance with the performance standard for laser
products in that the product was incorrectly classified
in Class I and lacked the appropriate warning logotype
and aperture label required for a Class IV product.
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Class III -
NONE
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Vedco Sterile Water for Injection, 250 ml. Recall #V-073-1.
Code: Lot #201212 EXP 11/92.
Manufacturer: Wendt Professional Laboratories, Inc., Belle Plaine,
Minnesota.
Recalled by: Manufacturer, by letter May 20, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 10,260 bottles were distributed.
Reason: Nonsterility.
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Class III -
NONE
Medical Device Safety Alerts:
Product: Hope III Resuscitator, a manually operated resuscitator
used for emergency treatment of victims suffering from
respiratory failure:
(a) Pediatric Versions, Part Nos. 9135-0203 and 9135-0218;
(b) Adult Versions, Part Nos. 9135-0202, 9135-0201,
9135-0216 and 9135-0217. Safety Alert #M-025/026-1.
Code: All units.
Manufacturer: Ohmeda, Division of the BOC Group Inc., Orchard Park,
New York and Matrx Medical Inc., Orchard Park, New York
(purchased business from Ohmeda in July 1988).
Alerted by: Matrx Medical Inc., Orchard Park, New York, by
letter May 24, 1991.
Distribution: Nationwide and international.
Quantity: 25,601 units were distributed.
Reason: The patient valve of the Hope III Resuscitator is
subject to sticking and blocking exhalation as the
result of improper cleaning.