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.
April 2, 1997 97-14
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Eggnog Cheesecake, net weight 3 pounds 1
ounce. Recall #F-270-7.
CODE None.
MANUFACTURER Moonstruck Chocolatier, Portland, Oregon.
RECALLED BY Manufacturer, by telephone beginning on
November 27, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 100 cakes were distributed between October and
November.
REASON The products contain undeclared FD&C Yellow
No. 5, FD&C Yellow No. 6, FD&C Blue No.1 and
FD&C Red No.3.
_______________
PRODUCT Chewsey Fruits Candy, in 8 ounce packages.
Recall #F-273-7.
CODE None.
MANUFACTURER Rayge Candy Company, Bricktown, New Jersey.
RECALLED BY Manufacturer, by letter dated November 1,
1996, followed by visit by November 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 5 cases were distributed; firm estimates none
remains on the market.
REASON Product contains undeclared certified colors,
FD&C Yellow No. 5 & 6.
_______________
PRODUCT Pork & Beans in Tomato Sauce, in 16 ounce cans
distributed under Phillips and Gibbs labels.
Recall #F-276-7.
CODE Product is marked with a two line code on The
top line the involved are 36262 HPBS and 46262
HPSB and the second line has a military time
between 15:00 and 23:00 SEPT 98.
MANUFACTURER Hanover Foods Corporation, Hanover,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on January 10,
1997. Firm-initiated recall complete.
DISTRIBUTION Virginia, North Carolina, Pennsylvania,
Maryland.
QUANTITY Firm estimates none remains on the market.
REASON Some cans of product contain a small amount of
undeclared corn.
________________
PRODUCT Nations Winners brand Spark of Life "Multi-
Nutritional Drink with Whole Leaf Aloe Vera
Vitamins, Minerals, Enzymes, and Herbs", in 32
fluid ounce plastic containers.
Recall #F-278-7.
CODE Batch 3844 on bottom of containers.
MANUFACTURER Aloe Pro International, Farmers Branch, Texas.
RECALLED BY Manufacturer, by letter dated November 7,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Georgia.
QUANTITY 2,383 bottles were distributed.
REASON Product contains undeclared FD&C Yellow No. 5
and bears an incorrect Vitamin C label
declaration.
_______________
PRODUCT Joe's Bakery Cookies, in 16 ounce hard plastic
containers. Recall #F-279-7.
CODE None. Product has a short shelf life.
MANUFACTURER Carcione, Guiseppe & Costello, Maria, doing
business as Joe's Bakery, Brooklyn, New York.
RECALLED BY Manufacturer, by telephone on January 29,
1997, and February 5, 1997. Completed recall
resulted from sample analysis and followup by
the New York State Department of Agriculture
and Markets.
DISTRIBUTION New York.
QUANTITY Firm estimates none remains on the market.
-2-REASON Product contains the undeclared colors FD&C
Yellow No. 5 and FD&C Red 40.
_______________
PRODUCT Naturally Wholesome Banana Cake, in 2-1/2
ounce cellophane packages.
Recall #F-280-7.
CODE All codes including Jan 2 97.
MANUFACTURER Neighborhood Bakery, Inc., also known as Payoo
Industries, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter followed by visit .
Completed field correction (relabelling)
resulted from sample analysis and followup by
the New York State Department of Agriculture
and Markets.
DISTRIBUTION New York.
QUANTITY Firm estimates none remains on market.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Libby's Juicy Juice: (a) Tropical flavor; (b)
Grape flavor; (c) Cherry flavor;
(d) Punch flavor; (e) Variety Pack (Punch,
Grape and Cherry flavors).
Recall #F-246/250-7.
CODE (a) Product code 28000-39110, date codes
5-Aug-97 and 6-Aug-97, 250 ml tetra pak,
27/case
(b) Product code 28000-39210, date code
6-Aug-97, 250 ml tetra pak, 27/case
(c) Product code 28000-39410, date codes
7-Aug-97 and 8-Aug-97, 250 ml tetra pak,
27/case product code 28000-39960, date codes
4-Aug-97 and 5-Aug-97, 125 ml tetra pak,
44/case
(d) Product code 28000-39610, date codes
4-Aug-97, 5-Aug-97, and 8-Aug-97, 250 ml tetra
pak, 27/case
(e) Product code 28000-39920, date codes
6-Apr-97, 27-Apr-97, 28-Apr-97, 30-Apr-97,
1-May-97, 19-Jun-97, Jul-97 (all dates 07
through 31), and Aug-97 (all dates 01 through
31)
MANUFACTURER Sweet Ripe Drinks Ltd., Ontario, Canada
(finished product); Resero Company, Argentina
(juice concentrate).
RECALLED BY Nestle Beverage Company, San Francisco,
California, by letter faxed on December 13,
1996. Firm-initiated recall ongoing.
-3-DISTRIBUTION Maryland, Pennsylvania, Florida, New Jersey,
New York, Connecticut, Virgin Islands, North
Carolina, Virginia, Ohio, Maryland, Georgia,
Maine, Alabama.
QUANTITY 50,230 cases (27 per case) were distributed.
REASON One of the juice concentrates used as an
ingredient in these products was found to
contain added sweetener.
_______________
PRODUCT Stop & Shop Fruit Punch from Concentrate, in
8.5 fluid ounce containers.
Recall #F-274-7.
CODE EXP AUG 5/97 stamped at apex of container.
MANUFACTURER Fisher Brothers Brands Ltd., Quebec, Canada.
RECALLED BY The Stop & Shop Supermarket, North Quincy,
Massachusetts, by E-mail on February 28, 1997,
follow-up notification was sent on March 4,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Connecticut, Rhode Island, New
York, New Jersey.
QUANTITY 110 cases (8 3-packs per case) were
distributed.
REASON Product is contaminated with mold.
_______________
PRODUCT Hunter brand Smoked Oysters in cottonseed oil,
in 3.75 ounce (105g) metal cans.
Recall #F-277-7.
CODE OYSO BY2 5413 and 0YSO BY2 5421.
MANUFACTURER Shinjin Moolsan Company, Ltd., Kyungnam,
Korea.
RECALLED BY Consolidated Stores Corporation, Columbus,
Ohio, by E-Mail message sent on January 31,
1997, and February 3 and 21, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 318 cases (24 cans per case) were distributed.
REASON Oysters were found to be decomposed.
_______________
PRODUCT Carbonated Soft Drinks:
1. Pepsi Cola (10 fl. ozs., 12 fl. ozs., 20
fl. ozs., 1 Liter, 2 Liter, 3 Liter)
2. Caffeine Free Pepsi (12 fl. ozs., 2 Liter)
3. Diet Pepsi (10 fl. ozs., 12 fl. ozs., 20
fl. ozs., 2 Liter, 3 Liter)
4. Diet Caffeine Free Pepsi (12 fl. ozs., 2
Liter)
5. Josta (20 fl. ozs.)
6. Mountain Dew (10 fl. ozs., 12 fl. ozs., 20
fl. ozs., 1 Liter, 2 Liter, 3 Liter)
-4- 7. Diet Mountain Dew (12 fl. ozs., 20 fl.
ozs., 2 Liter, 3 Liter)
8. Caffeine Free Mountain Dew (12 fl. ozs.,
20 fl. ozs., 2 Liter)
9. Diet Caffeine Free Mountain Dew (2 Liter)
10. Orange Slice (12 fl. ozs.)
11. Dr. Pepper (12 fl. ozs., 20 fl. ozs., 2
Liter)
12. Diet Dr. Pepper (12 fl. ozs., 2 Liter)
13. 7-Up (12 fl. ozs., 20 fl. ozs., 2 Liter)
14. Diet 7-Up (12 fl. ozs., 20 fl. ozs., 2
Liter)
15. Cherry 7-Up (2 Liter)
16. Sunkist Orange (12 fl. ozs., 2 Liter)
17. Canada Dry Club Soda (10 fl. ozs.)
18. Canada Dry Ginger Ale (10 fl. ozs.)
19. Canada Dry Tonic (10 fl. ozs.)
20. All Sport Blue Ice (20 fl. ozs., 32 fl.
ozs., 64 fl. ozs.)
21. All Sport Cherry Slam (20 fl. ozs., 32
fl. ozs., 64 fl. ozs.)
22. All Sport Fruit Punch (12 fl. ozs., 20 fl.
ozs., 32 fl. ozs., 64 fl. ozs.)
23. All Sport Grape (12 fl. ozs., 20 fl.
ozs., 32 fl. ozs., 64 fl. ozs.)
24-7 All Sport Lemon Lime (12 fl. ozs., 20
fl. ozs., 32 fl. ozs., 64 fl. ozs.)
25. All Sport Orange (12 fl. ozs., 20 fl.
ozs., 32 fl. ozs., 64 fl. ozs.)
26. Pepsi Cola Premix
27. Diet Pepsi Premix
28. Mountain Dew Premix
29. Dr. Pepper Premix. Recall #F-281/309-7.
CODE 1. 10 fl. ozs. xxxxTS021273
12 fl. ozs. xxxxTS020771
xxxxTS021271
20 fl. ozs. xxxxTS020673, xxxxTS021073
1 Liter xxxxTS021373
2 Liter xxxxTS020672
xxxxTS020772, xxxxTS021072
xxxxTS021272, xxxxTS021372
3 Liter xxxxTS021372
2. 12 fl. ozs. xxxxTS021071
2 Liter xxxxTS021072
3. 10 fl. ozs. xxxxTS021273
12 fl. ozs. xxxxTS021071, xxxxTS021471
20 fl. ozs. xxxxTS020673, xxxxTS021173
2 Liter xxxxTS021172
3 Liter xxxxTS021372
4. 12 fl. ozs. xxxxTS020671, xxxxTS021071
2 Liter xxxxTS021072
5. 20 fl. ozs. xxxxTS021173
-5- 6. 10 fl. ozs. xxxxTS021273
12 fl. ozs. xxxxTS020671, xxxxTS021171
xxxxTS021371
20 fl. ozs. xxxxTS020673, xxxxTS021073
xxxxTS021173
1 Liter xxxxTS021373
2 Liter xxxxTS021272, xxxxTS021372
3 Liter xxxxTS021372
7. 12 fl. ozs. xxxxTS021071, xxxxTS021471
20 fl. ozs. xxxxTS020673, xxxxTS021173
2 Liter xxxxTS020672, xxxxTS021172
3 Liter xxxxTS021372
8. 12 fl. ozs. xxxxTS021271
20 fl. ozs. xxxxTS021173
2 Liter xxxxTS021272
9. 2 Liter xxxxTS021172
10. 12 fl. ozs. xxxxTS020671, xxxxTS021171
11. 12 fl. ozs. xxxxTS021171
20 fl. ozs. xxxxTS021173
2 Liter xxxxTS020672, xxxxTS021172
12. 12 fl. ozs. xxxxTS021271
2 Liter xxxxTS020672
13. 12 fl. ozs. xxxxTS021171
20 fl. ozs. xxxxTS021173
2 Liter xxxxTS020672, xxxxTS021172
xxxxTS021272
14. 12 fl. ozs. xxxxTS021171
20 fl. ozs. xxxxTS021073
2 Liter xxxxTS020772, xxxxTS021172
15. 2 Liter xxxxTS020772
16. 12 fl. ozs. xxxxTS020671, xxxxTS021271
2 Liter xxxxTS021072
17. 10 fl. ozs. xxxxTS021273
18. 10 fl. ozs. xxxxTS021273
19. 10 fl. ozs. xxxxTS021273
20. 20 fl. ozs. xxxxTS020873, xxxxTS021473
32 fl. ozs. xxxxTS020873
64 fl. ozs. xxxxTS021473
21. 20 fl. ozs. xxxxTS020873, xxxxTS021473
32 fl. ozs. xxxxTS020873
64 fl. ozs. xxxxTS020873
22. 12 fl. ozs. xxxxTS020771, xxxxTS021471
20 fl. ozs. xxxxTS020873
32 fl. ozs. xxxxTS020873
64 fl. ozs. xxxxTS020873, xxxxTS021473
23. 12 fl. ozs. xxxxTS020771
20 fl. ozs. xxxxTS020873
32 fl. ozs. xxxxTS020873
64 fl. ozs. xxxxTS020873, xxxxTS021473
24. 12 fl. ozs. xxxxTS020771, xxxxTS021471
20 fl. ozs. xxxxTS020873, xxxxTS021473
32 fl. ozs. xxxxTS020873
64 fl. ozs. xxxxTS020873
-6- 25. 12 fl. ozs. xxxxTS021471
20 fl. ozs. xxxxTS020873
32 fl. ozs. xxxxTS020873
64 fl. ozs. xxxxTS021473
26. Nov 17, 97
27. May 26, 97
28. Aug 18, 97
29. Nov 10, 97.
MANUFACTURER PepsiCo South, Knoxville, Tennessee.
RECALLED BY Manufacturer, by visit to be completed by
close of business on February 21, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Tennessee and Georgia.
QUANTITY Approximately 137,000 cases (all sizes and
package types) were distributed; firm
estimated that the majority of these cases
would have been consumed prior to the
initiation of recall.
REASON Products have an off-odor and off taste.
_______________
PRODUCT America's Choice Thick and Chunky Hot Salsa,
packed in 26 ounce glass jars.
Recall #F-314-7.
CODE "B7B19 41 stamped on jar caps, B7B19 stamped
on shipping cases.
MANUFACTURER Torbitt & Castleman Company, Buckner,
Kentucky.
RECALLED BY Manufacturer, by mail on March 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Georgia, Vermont, New Jersey.
QUANTITY 55 cases (12 jars per case) were distributed;
firm estimates none remains on the market.
REASON Product was under processed, causing it to
ferment and pop lids off of the product.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
UPDATE UDL Laboratories (Rockford, Illinois),
Cefaclor Capsules, USP, 250 mg and 500 mg,
Recall #D-130/131-7, which appeared in the
March 26, 1997, Enforcement Report should
read: Product is unit dose packaged in 10
strips of 10 capsules per shelf carton.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-291/294-7.
-7-CODE Unit numbers: (a&b) 1117668, 1136572,
1214792; (c) 1117668, 1214792; (d) 1136572.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by letter dated May 24, 1996.
Firm-initiated recall complete.
DISTRIBUTION Kentucky, Ohio.
QUANTITY (a) 3 units; (b) 3 units; (c) 2 units; (d) 1
unit was distributed.
REASON Blood products were collected from a donor who
initially tested HCV reactive was not deferred
nor properly reentered.
_______________
PRODUCT Red Blood Cells. Recall #B-487-7.
CODE Unit numbers: 53Q55219, 53Q54223, 53Q53198.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated October 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland, Pennsylvania, District of Columbia.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor who
reported travel to an area considered endemic
for malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-478-7.
CODE Unit numbers: M38039, M37526, M36994, M36262.
MANUFACTURER Tri-Counties Blood Bank, Inc., Santa Barbara,
California.
RECALLED BY Manufacturer, by letter dated January 20,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 4 units were distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-492-7.
CODE Unit #26146-0328.
MANUFACTURER Blood Systems, Inc., Rogers, Arkansas.
RECALLED BY United Blood Services, Fort Smith, Arkansas,
by telephone on July 19, 1996. Firm-initiated
recall complete.
DISTRIBUTION Arkansas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.
-8-_______________
PRODUCT Red Blood Cells. Recall #B-493-7.
CODE Unit numbers: 12LF01581, 12LF04609,
12LF06740, 12LZ06324, 12LZ08584, 12LZ11633,
12LF12388, 12LF16806, 12LF18747, 12LF21411,
12LC19144, 12FZ11305, 12FZ13413, 12FZ20291,
12FZ22623, 12FZ24416, 12FZ15942, 12FZ18198.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated May 1, 3, 1996,
or July 5, 1995. Firm-initiated recall
complete.
DISTRIBUTION North Carolina.
QUANTITY 18 units were distributed.
REASON Blood products tested negative for the
antibody to the hepatitis B core antigen
(anti-HBc), but were collected from a donor
who previously tested repeatedly reactive for
anti-HBc on two separate occasions.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c)
Fresh Frozen Plasma. Recall #B-496/498-7.
CODE Unit numbers: 12C55093, 12E61490, 12GE10063,
12E70173, 12GH46339, 12GC31099, 12GH52169,
12GE23620, 12GH60568.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated May 10, 1996 or
May 21, 1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY (a) 1 unit; (b) 8 units; (c) 1 unit was
distributed.
REASON Blood products tested negative for the
antibody to the hepatitis B core antigen
(anti-HBc), were collected from a donor who
previously tested repeatedly reactive for
anti-HBc on two separate occasions.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-499/500-7.
CODE Unit #12FL83579.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letters dated January 22 and
23, 1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit of each component was distributed.
-9-REASON Blood products tested negative for the
antibody to the hepatitis C virus encoded
antigen (anti-HCV), were collected from a
donor who previously tested repeatedly
reactive for anti-HCV.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-501/503-7.
CODE Unit numbers: (a & b) 12LJ02816; (c)
12FV35378.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated January 22,
1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the hepatitis C virus encoded
antigen (anti-HCV), were collected from a
donor who previously tested repeatedly
reactive for anti-HCV.
_______________
PRODUCT Red Blood Cells. Recall #B-505-7.
CODE Unit #12LJ18563.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated June 17, 1996.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
emigrated from an area considered endemic for
malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-506-7.
CODE Unit #12GE20198.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated January 31,
1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the antibody
to the hepatitis B core antigen (anti-HBc),
but were collected from a donor who previously
tested repeatedly for anti-HBc on two separate
occasions.
-10-_______________
PRODUCT Red Blood Cells. Recall #B-508-7.
CODE Unit #12GC27932.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated May 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the antibody
to the hepatitis B core antigen (anti-HBc),
but was collected from a donor who previously
tested repeatedly for anti-HBc on two separate
occasions.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-509/511-7.
CODE Unit numbers: (a) 12E77883, 12R54653;
(b&c) 12E77883.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated May 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY (a) 2 units; (b&c) 1 unit was distributed.
REASON Blood products tested negative for the
antibody to the hepatitis B core antigen
(anti-HBc), but were collected from a donor
who previously tested repeatedly reactive for
anti-HBc on two separate occasions.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells.
Recall #B-512/513-7.
CODE Unit numbers: (a) 12FF72206; (b) 12GC43841,
12FC45478.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letters dated April 18, 19,
or 25, 1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY (a) 1 unit; (b) 2 units were distributed.
REASON Blood products tested negative for the
antibody to the hepatitis B core antigen
(anti-HBc) were collected from a donor who
previously tested repeatedly reactive for
anti-HBc on two separate occasions.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets, Pheresis.
Recall #B-514/515-7.
-11-CODE Unit numbers: (a) 12LJ18519; (b) 12GP03643,
12GP03842.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated May 29, 1996.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY (a) 1 unit; (b) 2 units were distributed.
REASON Blood products tested negative for the
antibody to the hepatitis B core antigen
(anti-HBc), but were collected from a donor
who previously tested repeatedly reactive for
anti-HBc on two separate occasions.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-516/518-7.
CODE Unit numbers: (a) 12LC05579, 12L98175,
12L12938; (b&c) 12LC05579.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated July 9 or 18,
1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY (a) 3 units; (b & c) 1 unit was distributed.
REASON Blood products tested negative for the
antibody to the hepatitis B core antigen
(anti-HBc), but were collected from a donor
who previously tested repeatedly reactive for
anti-HBc on two separate occasions.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-519/521-7.
CODE Unit numbers: (a) 12FH60303, 12FP00085,
12FX19419; (b) 12FH60303; (c) 12FH60303,
12FX19419.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letters dated July 8, 10, or
12, 1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY (a) 3 units; (b) 1 unit; (c) 2 units were
distributed.
REASON Blood products tested negative for the
antibody to the hepatitis B core antigen
(anti-HBc), but were collected from a donor
who previously tested repeatedly reactive for
anti-HBc on two separate occasions.
_______________
PRODUCT Platelets, Pheresis. Recall #B-522-7.
CODE Unit #1314-1275-02.
-12-MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Manufacturer, by telephone on July 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-524/525-7.
CODE Unit numbers: 53Q55615, 53Q54322, 53Q53223.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated October 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland and District of Columbia.
QUANTITY 3 units of each component were distributed.
REASON Blood products were collected from a donor who
reported travel to an area considered endemic
for malaria.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-526/527-7.
CODE Unit #49S53709.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letter dated December 27,
1996. Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported travel to an area considered endemic
for malaria.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-494/495-7.
CODE Unit #KE49457.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter on June 3, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
whose donor history screening was inadequately
performed.
-13-_______________
PRODUCT Red Blood Cells. Recall #B-504-7.
CODE Unit #12FZ30252.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated May 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at unacceptable
temperature.
_______________
PRODUCT Red Blood Cells. Recall #B-523-7.
CODE Unit #26146-4190.
MANUFACTURER United Blood Services, Fort Smith, Arkansas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arkansas, by
letter dated October 16, 1996. Firm-initiated
recall complete.
DISTRIBUTION Arkasas.
QUANTITY 1 unit was distributed.
REASON Blood product may have remained at room
temperature for an unacceptable length of
time.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT 7200 Series Ventilators System with Pulsed
Alarm Option and Pulsed Alarm Kits.
Recall #Z-349-7.
CODE Lot numbers 704 and 729.
MANUFACTURER Nellcor Puritan Bennett, Carlsbad, California.
RECALLED BY Manufacturer, by telephone and by fax dated
August 22, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, France, New Zealand, Canada.
QUANTITY 70 units were distributed.
REASON The optional pulsed alarm was not loud enough
for the user facilities to hear.
_______________
PRODUCT Airway Modules with Optional Spirometry
Functions used with the AS/3 Anesthesia
Monitor:
(a) Model G-AOV, Measure C02, N20, 02
Anesthetic Agent with Side Stream Spirometry;
(b) Model No. G-AiOV, Measure C02, N20, 02
Anesthetic Agent Side Stream Spirometry.
Recall #Z-350/351-7.
CODE Modules: G-AOV, G-AiOV
MANUFACTURER Datex-Engstrom Division, Helsinki, Finland.
-14-RECALLED BY Datex-Engstrom, Inc., Tewksbury,
Massachusetts, by letter dated January 10,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 26 units; (b) 760 units were distributed.
REASON A defective tantalum capacitor (C17) on the
PVX Board (pressure and volume measurement)
partly burned and short-circuited, resulting
in the spread of fire to the tubing and some
plastic parts inside the module.
_______________
PRODUCT Fluoroscan I and III Promotional Videotape,
with a 1992 copyright at the end of the tape.
Recall #Z-353-7.
CODE All tapes distributed prior to August 1996.
MANUFACTURER FluoroScan Imaging Systems, Inc., Northbrook,
Illinois.
RECALLED BY Manufacturer, by undated letter sent on March
14, 1997. Firm-initiated field correction
ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON The device has indications that extend the use
of the device beyond extremity imaging.
_______________
PRODUCT ImmunoCard H. pylori, Catalog #710030, used
for the detection of IgG antibodies to
Helicobacter pylori in human serum and plasma.
Recall #Z-354-7.
CODE Lot #710030.024.
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY Manufacturer, by telephone on February 25,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Italy.
QUANTITY 206 kits were distributed.
REASON The enzyme conjugate reagent causes false
positive results with patient specimens and
the negative control.
_______________
PRODUCT Hewlett Packard Ultrasound Transducers,
transducer frequencies are available for a
variety of imaging applications, including
abdominal and cardiac, fetal imaging and
neonatal head. Recall #Z-355/374-7.
CODE Model Serial Description
21200C 3412AOO651 2.5 MHz transducer
3412AO6749
3412AO6961
-15- 21202A 3412AO5578 2.5 NHz / 2.0 MHz
3412AO5594 transducer
21205C 3412AO2644 3.5 MHz transducer
3412AO2667
21210B 3412AO2731 5.0 MHz medium focus
transducer
21211B 3412AO2761 5.0 MHz short focus
3412AO2812 transducer
3412AO2840
3412AO2927
21215A 3425AOI301 2.5 MHz / 2.0 MHz
transducer
21253A 3412AOO531 3.5 MHz CLA transducer
21253B 3519AOO278 3.5 MHz CLA transducer
3519AOO2807
3519AOO285
3519AOO301
3519AOO304
3519AOO459
3519AOO478
354OA00123
354OA00131
3542AOO373
21255B 3412AOO497 4.5 MHz / 3.5 MHz
trapezoidal transducer
21958B 3507AOO962 7.5 MHz / 5.5 MHz
3507AOII69 trapezoidal linear array
3507AOI365 transducer
3507AOI366
3507AO1402
3507AO1419
3542AO1786
3542AO1799
3542AO1911
21275A 3434AO1447 7.5 MHz / 5.5 MHz
transducer
21302A 3426AOO215 2.5 MHz/ 2.0 MHz
transducer
21358B 3507AOO275 7.5 MHz / 5.5 MHz
3507AOO292 trapezoidal linear array
transducer
21363A 3412AOO577 5.0 MHz Biplane TEE
transducer
21370A 3441AOO1O4 7.5 MHz / 5.0 MHz
3441AOO125 Endovaginal transducer
3441AOO191
3441AOO195
3441AOO201
3441AOO204
3441AOO217
3441AOO265
3441AOO283
-16- 3441AOO285
3441AOO413
21372A 3551AOO138 7.5 MHz 5.0 MHz Small
3618AOO206 Parts CLA transducer
3618AOO210
21373A 3513AOO225 5.0 MHz Curvilinear
3513AOO250 transducer
3513AOO290
3513AOO356
21402A 2917AO3855 2.5 MHz CW/I Sonos 100
3312AO2631 transducer
3312AO3058
3312AO9754
3312AO9762
3312AO9763
3312AO9764
3312AO9766
3312AO9768
3312AO9769
3312AO9771
3312AO9824
3312A10478
3312A11946
3312A11965
3312A12480
21415A 3312AO8809 7.5 MHz Sonos 100
3312A11035 imaging transducer
3312A11440
21445A 3104AO4865 10MHZ imaging
transducer
MANUFACTURER Hewlett Packard Company, Andover,
Massachusetts.
RECALLED BY Manufacturer, by letter dated January 27,
1997. Firm-initiated field correction
ongoing.
DISTRIBUTION California, Colorado, Florida, Georgia,
Kentucky, Minnesota, Montana, New York, Ohio,
international.
QUANTITY 86 transducers were distributed.
REASON There may be slight image degradation.
_______________
PRODUCT Argyle Turkel Safety Toracentesis System and
Procedure Tray:
(a) Argyle Turkel Safety Thoracentesis System,
Catalog No. 8888-566034,
(b) Argyle Turkel Safety Thoracentesis
Procedure Tray, Catalog No. 8888-566059.
Recall #Z-375-376-7.
CODE Lot Numbers: (a) WO80333A, WO80334A,
WO80335A, WO81348A, WO81349A, WO83279A,
WO85088A, WO85089A, WO86537A, WO86538A,
-17- WO86539A, WO86540A, WO87939A, WO87938A,
WO87937A, WO99165A, WO99167A, WO102803A,
WO99166A, WO102804A, WO99168A, WO93348A,
WO105541A, WO105540A, WO93349A, WO106947A,
WO106949A, WO102802A, WO105539A, WO106948A;
(b) 899874, 800151, 800555, 800812, 800811,
801090, 801353, 801658, 802195.
MANUFACTURER Boston Scientific Company, Miami, Florida
(single device).
RECALLED BY Sherwood Davis & Geck, St. Louis, Missouri, by
letter dated February 14, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 13,789 systems; (b) 20,447 trays were
distributed between 1/18/96-2/4/97.
REASON The one-way safety ball valve in the devices
may malfunction allowing air leakage into the
pleural space.
_______________
PRODUCT Solar 7000/8000 Patient Monitors, used with
Solar ECG/12SL Modules, to display
physiological data from modules which monitor
the patient for ECG, blood pressure, etc.
Recall #Z-377-7.
CODE All versions of software prior to Version 3.
MANUFACTURER Marquette Electronics, Inc., Milwaukee,
Wisconsin.
RECALLED BY Manufacturer, by letter sent on February 14,
1997. Firm-initiated field correction
ongoing.
DISTRIBUTION Maryland, Minnesota, Texas, Italy, India.
QUANTITY 48 Solar ECG/12SL Modules were distributed.
Only the Solar 7000/8000 Patient Monitors used
with Solar ECG/12SL Modules are affected and
the software in these monitors is to be
replaced.
REASON The device produces output which is incorrect.
(The data from one patient lead replaces the
data from another patient lead.)
_______________
PRODUCT Abbott TestPack Strep A, in-vitro diagnostic
enzyme immunoassay for the rapid detection and
confirmation of group A Streptococci from
throat specimens: List #1301-22, 40 Tests,
List #1301-82, 80 Tests. Recall #Z-378-7.
CODE Lot numbers: 21937M200 (40 tests);
22515M300 (80 tests).
MANUFACTURER Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY Manufacturer, by telephone on January 16, 17,
1997, followed by letter dated January 1997.
Firm-initiated recall complete.
-18-DISTRIBUTION Nationwide, Italy, Germany.
QUANTITY 231 40-test kits and 123 80-test kits were
distributed.
REASON Devices can cause false positive results with
patient specimens and the negative controls.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Paragon Screw-Vent Implant (SVA-16), a dental
screw-type implant, packaged in a clear vial.
Recall #Z-352-7.
CODE Lot #074-10/99.
MANUFACTURER Core BioEngineering Calabasas, California and
Core-Vent Corporation, Las Vegas, Nevada.
RECALLED BY Core-Vent Corporation, Las Vegas, Nevada, by
telephone on January 31, 1997, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin, Connecticut, Pennsylvania, New
York, Utah, Massachusetts, Colorado, Ohio,
California, Indiana, Maryland, Florida.
QUANTITY 401 units were distributed.
REASON Some Screw-Vent dental implants were labeled
with incorrect dimensions and part numbers
that did not reflect the actual measured
values of the product.
_______________
PRODUCT Clintec Model 2200 Enteral Feeding Pump, used
in the administration of all enteral feeding
formulas. Recall #Z-348-7.
CODE Serial numbers: 16304 through 16603.
MANUFACTURER Elan Pharma Inc., Smithfield, Rhode Island.
RECALLED BY Manufacturer, by letters on March 23, 1995,
May 3 and 10, 1995. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide.
QUANTITY 299 pumps were distributed.
REASON The pumps may have been manufactured with the
incorrect instruction labels.
-19-
END OF ENFORCEMENT REPORT FOR APRIL 2, 1997. BLANK PAGES MAY
FOLLOW.
####
End of Enforcement Report for
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