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.
June 16, 1999 99-24
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Parkside Candy, "Deluxe Assortment" boxed chocolate assortments,
sold in 8 ounce, 16 ounce and 32 ounce boxes. Recall #F-448-9.
CODE
None.
MANUFACTURER
Parkside Candy, Company, Buffalo, New York.
RECALLED BY
Manufacturer, by visit on April 8, 1999. Completed recall
resulted from sample analysis and follow-up by the New York State
Department of Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
Undetermined.
REASON
Product lists "nut meats" as an ingredient without listing the
individual nuts. In addition, the product contains peanut
residue.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________
PRODUCT
St. John's Wort Capsules, 250 mg, under the Aurora Healthcare and
Nature's Blend labels, 60 capsules per bottle.
Recall #F-441-9.
CODE
A8-87 and W7-81.
MANUFACTURER
National Vitamin Company, Inc., Porterville, California.
RECALLED BY
Manufacturer, by letter on March 12, 1999, followed by visit.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
23,679 bottles were distributed.
REASON
Products contain less hypericin than the amount declared on the
label. Lot A8-87 contains <36% and lot W7-81 contains 12% of the amount hypericin declared. _________ PRODUCT
Minute Maid Premium 100% Orange Juice from concentrate in 8.45
ounce (250 ml) aseptic drink box containers.
Recall #F-446-9.
CODE
Expiration Dates JUL0799 and JUL0899.
MANUFACTURER
Whitlock Packaging Corporation, Fort Gibson, Oklahoma.
RECALLED BY
The Minute Maid Company, Houston, Texas, by visit on April 22,
1999. Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
3,018 cases of 27 cartons each were distributed.
REASON
Product may be contaminated with mold.
________
PRODUCT
Big K (Kroger brand) Koolers Sweet Tea, in 11.5 fluid ounce cans.
Recall #F-447-9.
CODE
Sell by 15 SEP 99 CVSA.
MANUFACTURER
Springdale Ice Cream & Beverage, Cincinnati, Ohio.
RECALLED BY
The Kroger Company, Cincinnati, Ohio, by electronic mail on April
21, 1999, followed by telephone and fax. Completed recall
resulted from sample analysis and follow-up by the Indiana State
Department of Health, Food Protection Program (ISDH).
DISTRIBUTION
Georgia, Alabama, South Carolina, Indiana, Kentucky, Ohio, West
Virginia, Illinois, Missouri, Michigan, Tennessee, Virginia,
North Carolina.
QUANTITY
8,697 cases (104,364) cans were distributed.
REASON
Product may be contaminated with yeast.
_________
PRODUCT
Liothyronine Sodium, USP, bulk powder in 1 and 5 gram containers,
Rx for the treatment of hypothyroidism.
Recall #D-243-9.
CODE
9802163, 971257, 9808168, and 9802133.
MANUFACTURER
Gallipot, Inc., St. Paul, Minnesota.
RECALLED BY
Manufacturer, by telephone on or about January 28, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
2 5-g containers and 10 1-gallon containers were distributed.
REASON
Product is Mislabeled - Actually contains Levothyroxine Sodium.
________
PRODUCT
Bromocriptine Mesylate, USP, Rx used to reduce tumor size prior
to performing surgeries: a) Bromocriptine Mesylate Tablets 2.5
mg, in 30 and 100 count bottles, under the Rosemont and Mylan
labels; b) Bromocriptine Mesylate Capsules 5 mg, in 30 and 100
count bottles under the Rosemont label. Recall #D-245/246-9.
CODE
All lots within expiration date.
MANUFACTURER
Lek Pharmaceutical and Chemical Company, Ljubijana, Slovenia.
RECALLED BY
Lek, USA Englewood Cliffs, New Jersey, by telephone and fax on
March 9, 1999, and by letter dated April 1, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Colorado.
QUANTITY
a) 6,678,000 bottles; b) 881,000 bottles were distributed.
REASON
Lack of assurance of bioequivalence.
________
PRODUCT
Levothyroxine Sodium Tablets, Rx in bottles of 100 and 1000, used
as a replacement or supplemental therapy in patients with
hypothyroidism and as a pituitary TSH suppressant in the
treatment or prevention of various types of euthyroid goiters:
a) 25 mcg (0.025mg); b) .50 mg (0.05mg);
c) 150 mcg (.15mg); d) 300 mcg (.3mg). Recall #D-256/259-9.
CODE
a) Levothyroxine Sodium 0.025mg Rx Tablets, lot #'s:
004097A, exp. 02/99 (NDC #0254-3911-28)
004097B, exp. 02/99 (NDC #0254-3911-28)
004097C, exp. 02/99 (NDC #0603-4192-32)
047117D, exp. 05/99 (NDC #0603-4192-32)
047117E, exp. 05/99 (NDC #0254-3911-38)
047117G, exp. 05/99 (NDC #0677-1648-01)
047117H, exp. 05/99 (NDC #0677-1648-10)
032127A, exp. 05/99 (NDC #0254-3911-28)
032127B, exp. 05/99 (NDC #0254-3911-38)
032127C, exp. 05/99 (NDC #0254-4192-21)
032127D, exp. 05/99 (NDC #0603-4192-32)
033127B, exp. 05/99 (NDC #0603-4192-21)
033127C, exp. 05/99 (NDC #0603-4192-32)
033127D, exp. 05/99 (NDC #0254-3911-28)
033127E, exp. 05/99 (NDC #0254-3911-38)
b) Levothyroxine Sodium 0.05mg Rx Tablets, lot #'s:
005097A, exp. 02/99 (NDC #0254-3912-38)
005097F, exp. 02/99 (NDC #0254-3912-38)
006097A, exp. 02/99 (NDC #0603-4193-32)
004127A, exp. 05/99 (NDC #0603-4193-21)
004127B, exp. 05/99 (NDC #0254-3912-28)
004127C, exp. 05/99 (NDC #0603-4193-32)
c) Levothyroxine Sodium 0.150mg Tablets, lot #'s:
044087A, exp. 07/99 (NDC #0603-4196-21)
044087B, exp. 07/99 (NDC #0254-3915-28)
044087C, exp. 07/99 (NDC #0677-0992-01)
044087D, exp. 07/99 (NDC #0254-3915-38)
044087E, exp. 07/99 (NDC #0603-4196-32)
d) Levothyroxine Sodium 0.3mg Rx Tablets, lot #'s:
017047C, exp. 03/99 (NDC #0254-3917-28)
017047D, exp. 03/99 (NDC #0254-3917-28)
017047F, exp. 03/99 (NDC #0254-3917-28)
017047G, exp. 03/99 (NDC #0603-4198-21)
017047B, exp. 03/99 (NDC #0603-3917-38).
MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.
RECALLED BY
Manufacturer, by letter dated November 11, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION
Alabama.
QUANTITY
4800 bottles of Levothyroxine Sodium 0.025mg, lot #004097A.
6077 bottles of Levothyroxine Sodium 0.025mg, lot #004097B.
954 bottles of Levothyroxine Sodium 0.025mg, lot #004097C.
532 bottles of Levothyroxine Sodium 0.025mg, lot #047117D.
1369 bottles of Levothyroxine Sodium 0.025mg, lot #047117E.
1421 bottles of Levothyroxine Sodium 0.025mg, lot #047117G.
838 bottles of Levothyroxine Sodium 0.025mg, lot #047117H.
4192 bottles of Levothyroxine Sodium 0.025mg, lot #032127A.
1208 bottles of Levothyroxine Sodium 0.025mg, lot #032127B.
2772 bottles of Levothyroxine Sodium 0.025mg, lot #032127C.
984 bottles of Levothyroxine Sodium 0.025mg, lot #032127D.
2592 bottles of Levothyroxine Sodium 0.025mg, lot #033127B.
1800 bottles of Levothyroxine Sodium 0.025mg, lot #033127C.
2527 bottles of Levothyroxine Sodium 0.025mg, lot #033127D.
600 bottles of Levothyroxine Sodium 0.025mg, lot #033127E.
1179 bottles of Levothyroxine Sodium 0.05mg, lot #005097A.
804 bottles of Levothyroxine Sodium 0.05mg, lot #005097F.
3000 bottles of Levothyroxine Sodium 0.05mg, lot #006097A.
3192 bottles of Levothyroxine Sodium 0.05mg, lot #004127A.
9720 bottles of Levothyroxine Sodium 0.05mg, lot #004127B.
1074 bottles of Levothyroxine Sodium 0.05mg, lot #004127C.
652 bottles of Levothyroxine Sodium 0.3mg, lot #017047C.
1792 bottles of Levothyroxine Sodium 0.3mg, lot #017047D.
1440 bottles of Levothyroxine Sodium 0.3mg, lot #017047F.
1200 bottles of Levothyroxine Sodium 0.3mg, lot #017047G.
924 bottles of Levothyroxine Sodium 0.3mg, lot #017047B.
1407 bottles of Levothyroxine Sodium 0.150mg lot #044087A.
1784 bottles of Levothyroxine Sodium 0.150mg lot #044087B.
1195 bottles of Levothyroxine Sodium 0.150mg lot #044087C.
829 bottles of Levothyroxine Sodium 0.150mg lot #044087D.
589 bottles of Levothyroxine Sodium 0.150mg lot #044087E.
REASON
Lack of assurance of potency through expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Lycall Cold Sore Ointment (Lysine/Camphor/Menthol), in 8 gram
jars. Recall #D-242-9.
CODE
Lot #1541 EXP 23/01.
MANUFACTURER
Caleb Laboratories, Inc., Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by telephone beginning on April 28, 1999, and by
letter faxed on April 28, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Minnesota, Wisconsin, North Dakota, Colorado.
QUANTITY
924 jars were distributed.
REASON
Lysine subpotency.
________
PRODUCT
Rugby brand Calcium Carbonate Tablets, 10 gr (648 mg), in 1,000
tablet containers. Recall #D-244-9.
CODE
Lot #1795-8911 EXP 11/02.
MANUFACTURER
Tischon Corporation, Salisbury, Maryland.
RECALLED BY
Tishcon Corporation, Westbury, New York, by fax and certified
mail on April 12, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Georgia.
QUANTITY
1,005 bottles were distributed.
REASON
Tablet mix-up - Bottles contain brewer's yeast tablets (light
brown).
________
PRODUCT
Acyclovir Tablets or Capsules, Rx used as an anti-viral
medication for Herpes Simplex I:
a) 200 mg, in 100, 500 and 1,000 capsule bottles
b) 400 mg, Rx in 100, 500, and 1,000 tablet bottles
c) 800 mg, Rx in 100, 500, and 1,000 tablet bottles
Labels and NDC Numbers --
Schein Pharmaceuticals
0365-2692-01 100 capsules/200 mg
0364-2689-01 100 tablets/400 mg
0364-2689-05 500 tablets/400 mg
0364-2689-01 100 tablets/800 mg
Mylan Pharmaceutical Inc.
0378-1464-01 100 tablets/400 mg
0378-1468-01 100 tablets/800 mg
Par Pharmaceutical
49884-460-05 200 mg 500 capsules
49884-460-01 100 capsules
49884-460-10 1000 capsules
49884-487-01 400 mg 100 tablets
49884-487-05 500 tablets
49884-487-10 1000 tablets
49884-474-01 800 mg 100 tablets
49884-474-05 500 tablets
49884-474-10 1000 tablets
Cimetidine Tablets, used as a stomach acid reducer for patients
with stomach ulcers
d) 200 mg, Rx and OTC, in 6,10, 12,18, 30, 50, 60, 90, and 100
count units
e) 300 mg, Rx in 100, 500, and 1,000 count bottles
f) 400 mg, Rx in 60, 100, 500, and 1,000 count bottles
g) 800 mg, Rx in 30, 100, and 250 count bottles.
Labels and NDC Numbers--
Cimetidine 200 mg OTC
Firm Name NDC# Packaged Size
Eckerd Drug Company 19458-957-61 6 tablet blister
19458-957-62 18 tablet blister
19458-957-63 30 tablet blister
19458-957-64 60 tablet blister
Albertson's 41163-229-08 30 tablet blister
Equate 50606-229-08 30 tablet blister
Packaged by 50606-229-15 60 tablet blister
BI-MART 12 tablet blister
30 tablet blister
Western Family Foods, Inc. 12 tablet blister
30 tablet blister
Kaiser Permanente 00179-1308-30 30 tablet blister
00179-1308-90 90 tablet blister
Pharmacist Formula 18 tablet blister
Marketed by: (special 30 tablet blister for above)
Leiner Health Products, Inc. 30 tablet blister
50 tablet blister
VONS 58828-229-08 30 tablet blister
Safeway Inc. 21130-229-08 30 tablet blister
Bulk shipping label
LEK Pharmaceutical and Chemical Co., d.d.
Ljubljana, Slovenia 60x6 coated tablet blister
60x6 tablets acid reducer
60x10 tablets acid reducer
60x10 coated tablets
Cimetidine 200 mg, RX
Rosemont 0832-0101-00 100 tablet bottles
Brightstone 62939-2111-1 100 tablet bottles
Schein 364-2591-01 100 tablet bottles
0364-2591-01 100 tablet bottles
Martec 52555-708-01 100 tablet bottles
Qualitest 0603-2890-21 100 tablet bottles
URL 0677-1527-01 100 tablet bottles
Cimetidine 300 mg
Rosemont 0102-00 100 tablet bottles
0832-0102-50 500 tablet bottles
0832-0102-10 1000 tablet bottles
Brightstone 62939-2121-1 100 tablet bottles
Schein 0364-2592-01 100 tablet bottles
0364-2592-05 500 tablet bottles
Martec 52555-709-01 100 tablet bottles
Apothecon 59772-0229-5 500 tablet bottles
Qualitest 0603-2891-28 500 tablet bottles
URL 0677-1528-01 100 tablet bottles
MOVA 55370-866-07 100 tablet bottles
Cimetidine 400 mg
Rosemont 0832-0103-06 60 tablet bottles
0832-0103-00 100 tablet bottles
0832-0103-50 500 tablet bottles
0832-0103-10 1000 tablet bottles
Brightstone 62939-2131-1 100 tablet bottles
Martec 52555-710-01 100 tablet bottles
Schein 0364-2593-01 100 tablet bottles
0364-2593-05 500 tablet bottles
URL 0677-1529-01 100 tablet bottles
0677-1529-05 500 tablet bottles
Novapharm 55953-436-40 100 tablet bottles
55953-436-70 500 tablet bottles
55953-436-80 1000 tablet bottles
Apothecon 59772-0230-3 100 tablet bottles
59772-0230-7 500 tablet bottles
Qualitest 0603-2892-28 500 tablet bottles
Cimetidine 800 mg
Rosemont 0832-0104-03 30 tablet bottles
0832-0104-00 100 tablet bottles
0832-0104-25 250 tablet bottles
Martec 52555-711-01 100 tablet bottles
Novapharm 55953-516-40 100 tablet bottles
Schein 0364-2594-01 100 tablet bottles
0364-2594-01
Brightstone 62939-2141-1 100 tablet bottles
Qualitest 0603-2893-21 100 tablet bottles
Apothecon 59772-0231-3 100 tablet bottles
59772-0231-4 250 tablet bottles.
Recall #D-247/253-9.
CODE
All lots within expiration date.
MANUFACTURER
LEK Pharmaceutical and Chemical Company, Ljubljana, Slovenia.
RECALLED BY
LEK, USA Englewood Cliffs, New Jersey, by telephone or fax March
7 or 9, 1999, and by letter dated April 1 or 15, 1999. Firm-
initiated recall ongoing.
DISTRIBUTION
New Jersey, New York, West Virginia.
QUANTITY
Acyclovir Tablets -- 37,464 bottles (Par)
430,284 bottles (Schein)
740,000 bottles (Mylan)
Acyclovir Capsules -- 22,110 bottles (Par)
320,378 bottles (Schein)
Cimetidine Tablets --
200 mg OTC 11,026 blisters
200 mg RX 34,866 bottles
400 mg 307,813 bottles
800 mg 130,139 bottles were distributed.
REASON
Lack of assurance of bioequivalence.
________
PRODUCT
Astra 4% Citanest Forte with Epinephrine 1:200,000 (Prilocaine
and Epinephrine Injection, USP), in 1.8 mL cartons, indicated for
the production of local anesthesia in dentistry. NDC #0186-0540-
14. Recall #D-255-9.
CODE
Lot No. Expiration Date
0540801072 Jul-99
0540801075 Jul-99
0540802017 Aug-99
0540803036 Sep-99
0540803044 Sep-99
0540803053 Sep-99
0540803072 Sep-99
0540803090 Sep-99
0540804018 Oct-99
0540804023 Oct-99
0540804037 Oct-99
0540804049 Oct-99
0540804054 Oct-99
0540804103 Oct-99
0540804107 Oct-99
0540805001 Nov-99
MANUFACTURER
Astra Pharmaceuticals, L.P., Westborough, Massachusetts.
RECALLED BY
Manufacturer, by letter on May 28, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
56,252 units were distributed
REASON
Epinephrine subpotency (stability).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
a) Whole Blood; b) Red Blood Cells; c) Red Blood Cells,
Leukocytes Removed; d) Fresh Frozen Plasma; e) Recovered Plasma.
Recall #B-840/844-9.
CODE
Contact FDA, Center for Biologics Evaluation and Research, Office
of Compliance (301) 827-6220 for individual unit numbers
recalled.
MANUFACTURER
United Blood Services, Phoenix, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by fax or telephone on
January 29, 1999, and by letters dated February 25, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Arizona, Tennessee, Georgia, and Switzerland.
QUANTITY
a) 2 units; b) 40 units; c) 1 unit; d) 12 units; e) 17 units were
distributed.
REASON
Blood products were collected in a manner that compromises the
sterility of the units.
________
PRODUCT
Platelets. Recall #B-845-9.
CODE
Unit #19GJ45444.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by telephone on November 2, 1998, followed by
letter dated November 3, 1998. Firm-initiated recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor taking the drug
Methotrexate.
________
PRODUCT
National Biomedical Computer System, Versions 1.1 to 1.3.2.
Recall #B-861-9.
CODE
Software versions 1.1 to 1.3.2.
MANUFACTURER
American Red Cross Blood Services, Arlington, Virginia.
RECALLED BY
Manufacturer, by letter dated January 6, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
38 systems were distributed.
REASON
Y2K defect in the computer software incorrectly calculates the
end date of a temporary deferral to be 1900 instead of 2000, and
removes the deferral from the database.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
Recall #B-864/866-9.
CODE
Unit #24KL33003.
MANUFACTURER
American Red Cross Blood Services, Louisville, Kentucky.
RECALLED BY
Manufacturer, by letters dated December 9 and 10, 1998. Firm-
initiated recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who previously tested
positive for hepatitis.
________
PRODUCT
Platelets, Pheresis. Recall #B-867-9.
CODE
Unit #19GL23665.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by telephone on January 4, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable platelet yield.
________
PRODUCT
Red Blood Cells. Recall #B-868-9.
CODE
Unit numbers: 19GF56903 and 19GF53660.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letters dated November 23, 1998, and December
28, 1998. Firm-initiated recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from a donor who traveled to an
area considered endemic for malaria.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________
PRODUCT
Various Custom Allergenic extract Mixtures and Stock Extracts.
Recall #B-863-9.
CODE
A total of 637 different lot numbers are subject to recall.
MANUFACTURER
Allergy Laboratories of Ohio, Inc., Columbus, Ohio.
RECALLED BY
Manufacturer, by letter on either February 17, 1999, March 5, 8,
10, 11, 12, 15, 16, 17, or 18, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
1,521 vials were distributed.
REASON
Allergenic extracts were labeled with extended expiration dates.
________
PRODUCT
Fresh Frozen Plasma, Pheresis. Recall #B-881-9.
CODE
Unit #19GL15526.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by telephone on October 27, 1997. Firm-initiated
recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
1 unit was distributed.
REASON
Blood product may not have been frozen within the acceptable time
limit.
________
PRODUCT
Get Smart Be Prepared, 207 piece Emergency First Aid Kit.
Recall #Z-954-9.
CODE
Not coded -- Only the kits with a red cross on the label are
subject to recall.
MANUFACTURER
Total Resources International, Inc., Walnut, California.
RECALLED BY
Manufacturer, by letter dated April 22, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Pennsylvania, Maryland, Mississippi, Missouri, Arkansas,
Louisiana, Texas.
QUANTITY
5,000 first aid kits were distributed.
REASON
The Povidone Iodine pads in the kits are contaminated with
microorganisms such as Pseudomonas putida, Salmonella spp., Poly
D, and Aeromonas sorbia.
RECALLS AND FIELD CORRECTOINS: DEVICES -- CLASS II
________
PRODUCT
IiRAD DR1000C Digital Chest System, general purpose x-ray device.
Recall #Z-949-9.
CODE
Model IiRAD DR1000C.
MANUFACTURER
Fischer Imaging Corporation, Denver, Colorado.
RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan
June 1999. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2 units were distributed.
REASON
The units are defective under 21 CFR 1003.2 in that they do not
assure certification to field sizing specifications are met
because the system intermittently opens wide open in the vertical
direction when the exposure button is depressed. This can result
in the patient receiving excess exposure where no useful
diagnostic imaging can occur.
________
PRODUCT
CryoValve Allograft (heart valve), Model PV00.
Recall #Z-980-9.
CODE
Serial number 6553109.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter on March 26, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Utah.
QUANTITY
1 unit was distributed and subsequently destroyed.
REASON
The donorís final autopsy report, which included a histological
exam of the donorís brain, revealed evidence of viral
encephalitis.
________
PRODUCT
CryoValve Allograft (heart valve), Model PVOO.
Recall #Z-981-9.
CODE
Serial #6406157.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter on March 29, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Michigan.
QUANTITY
1 unit was distributed.
REASON
The donorís final autopsy report revealed undiagnosed Sarcoma
(Fibrosarcoma) of the right leg.
________
PRODUCT
CryoValve Allograft (heart valve):
a) Model No. AV40, Serial No. 6285082;
b) Model No. AV05, Serial No. 6314988. Recall #Z-982/983-9.
CODE
a) Serial No. 6285082; b) Serial No. 6314988.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter on April 1, 1999. Firm-initiated recall
complete.
DISTRIBUTION
a) Maryland; b) Texas.
QUANTITY
1 unit of each component was distributed.
REASON
The donors do not meet current guidelines regarding serodilution
of plasma because of the amount of transfused/infused fluids
administered.
________
UPDATE
Model CVX CVX-300 Excimer Laser, Recall #Z-934-9, which appeared
in the June 2, 1999 Enforcement Report should read: CODE
Serial numbers: 1468 thru 1502, 79600 79601 79602 79603
79605 79606 79610 thru 79631, 79805, 79806, 79807, 79808.
DISTRIBUTION: Nationwide, Argentina, Canada,
Europe.
QUANTITY: 67 units were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
UPDATE
Hemoglobin Reagent, Recall #Z-947-9 which appeared in the June 8,
1999 Enforcement Report is a Class III recall.
END OF ENFORCEMENT REPORT FOR JUNE 16, 1999.
####
