July 5, 2000 00-27
CODE
All product. Only the 16-ounce bottles are coded - Julian date of 020200 or
before.
MANFACTURER
Green Garden Food Products, Inc., Kent, Washington (contract manufacturer of 16-ounce
size).
RECALLED BY
Gourmet Mixes, Inc., Seattle, Washington, by telephone beginning on April 21, 2000,
by letter on April 26, 2000, by E-mail on April 27, 2000, and by press release on
April 21, 2000. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
Undetermined.
REASON
Products contain undeclared egg yolks, anchovies, and sulfites.
________
PRODUCT
Granny's Chuckwagon Sandwiches, net weight 6.20 ounce per sandwich, packed 40 frozen
sandwiches per box:
a) Chuckwagon Sandwich; b) Deli Combo Sandwich.
Recall #F-568/569-0.
CODE
a) Packed on dates 5/19/00 and 5/20/00; b) Sell by
JUN 11 00.
MANFACTURER
Landshire Fast Foods of Milwaukee, Inc., Muskego, Wisconsin.
RECALLED BY
Manufacturer, a) by telephone on May 31, 2000, followed by visit on June 5, 2000; b)
by letter dated June 1, 2000, followed by visit and telephone on May 19, 2000. Firm-
initiated recall ongoing.
DISTRIBUTION
Wisconsin and Illinois.
QUANTITY
a) 75 cases of 40 sandwiches per case; b) 159 sandwiches were distributed.
REASON
Products are contaminated with Listeria monocytogenes.
________
PRODUCT
Kroger Delicatessen Bright Sides brand Albacore Tuna Salad, in 16-ounce cans. Recall
#F-570-0.
CODE
USE BY MAY 17 and USE BY JUNE O8.
MANFACTURER
K.B. Specialty Foods, Greensburg, Indiana.
RECALLED BY
The Kroger Company, Cincinnati, Ohio, by telephone on May 20, 2000, followed by fax
and E-mail on May 22, 2000. Firm0initiated recall complete.
DISTRIBUTION
Michigan, Alaska, Mississippi, Missouri, Illinois, Tennessee, South Carolina,
Alabama, Indiana, Georgia.
QUANTITY
58 cases were distributed.
REASON
Product is contaminated with Listeria monocytogenes.
________
PRODUCT
Pimento Cheese Sandwiches, packaged in 4-ounce black flexible plastic. Recall #F-
575-0.
CODE
Sell by dates of 2-18-00 through 03-01-00.
MANFACTURER
Grand Strand Sandwich Company, Longs, South Carolina.
RECALLED BY
Manufacturer, by visit on February 21, 2000. Firm-initiated recall complete.
DISTRIBUTION
North Carolina and South Carolina.
QUANTITY
Approximately 2,262 sandwiches were distributed; firm estimates none remain on the
market.
REASON
Product may have been contaminated with Listeria monocytogenes.
________
PRODUCT
Various candies repacked by the recalling firm, sold in
1-pound clear plastic bags: a) Assorted Fruit Slices;
b) Raspberry Slices; c) Grapefruit Slices.
Recall #F-576/578-0.
CODE
None.
MANFACTURER
Premier Packing Company, Greenacres, Washington.
RECALLED BY
Manufacturer, by telephone on April 4, 2000, or by letter on April 21, 2000. Firm-
initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
Firm estimates none remains on the market.
REASON
Products contain undeclared egg albumen, FD&C Yellow No. 5, FD&C Yellow No. 6, and
FD&C Red No. 40.
________
PRODUCT
SYSCO Cake Products:
a) Apple Spice Layer Cake, 62-ounces, 9" (item 1581453)
b) Apple Streusel Sheet Cake, 72-ounce (item 1581479)
c) Variety Layer Cake, 9" (item 1581529).
Recall #F-595/597-0.
CODE
All lots on the market at the time of recall initiation.
MANFACTURER
Dan-Co Bakery, Inc., Forest Park, Georgia.
RECALLED BY
Mrs. Smith's Bakeries, Inc., Suwanee, Georgia, by letter on April 3, 2000. Firm
initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
a) 2,051 cases; b) 2,571 cases; c) 13, 995 cases were distributed.
REASON
a) Product contains undeclared walnuts;
b) Product contains undeclared pecans;
c) Product contains undeclared walnuts.
CODE
066A-4619 printed on outer carton.
MANFACTURER
Saprolait Vaudes, St. Parres, France.
RECALLED BY
The World's Best Cheeses, Inc., Armonk, New York, by telephone and visit on April 3,
2000. Firm-initiated recall complete.
DISTRIBUTION
New York, and New Jersey.
QUANTITY
Firm estimates none remains on the market.
REASON
The manufacturer of the cheese is not certified by the French government to export
this type of product to the USA.
________
PRODUCT
Pasteurized Liquid Salt Yolk (C-mix [2/3 yolk, 1/3 whole egg and 10% salt]). Recall
#F-573-0.
CODE
Lot #310-9.
MANFACTURER
Db Foods, Inc., Springdale, Arkansas.
RECALLED BY
Manufacturer, by telephone on November 12, 1999, Followed by letter. Firm-initiated
recall complete.
DISTRIBUTION
California.
QUANTITY
44,980 pounds were distributed; firm estimates none remains on the market.
REASON
Product was contaminated with Salmonella.
________
PRODUCT
Various candies repacked by the recalling firm, sold in
1-pound clear plastic bags: a) Assorted Jelly Beans;
b) Pectin Fruit Slices; c) Gummi Bear Chews;
d) Licorice Mix; e) Pebble Rock Candy; f) Lemon Drops;
g) Old Fashioned Ribbon Candy; h) Salt Water Taffy;
i) Fruitcake Assorted Mix; j) Green Candied Cherries;
k) Licorice Pastels; l) Papaya Chunks; m) Fiesta Mix;
n) Inferno Mix. Recall #F-579-592-0.
CODE
None.
MANFACTURER
Premier Packing Company, Greenacres, Washington.
RECALLED BY
Manufacturer, by telephone on April 4, 2000, or by letter on April 21, 2000. Firm-
initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
Firm estimates none remains on the market.
REASON
Products contained the following undeclared ingredients:
a) FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 40, and FD&C Blue No. 1.
b) FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 3, FD&C Blue No. 2 Lake, FD&C Yellow No. 6 Lake, and FD&C Red No. 40 Lake.
c) FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40.
d) Flour, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 40, FD&C Red
No. 3, and FD&C Blue No. 1.
e) FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Red No. 40, FD&C Red No. 3, FD&C Blue #2 Lake, FD&C Yellow No. 6 Lake, and FD&C Red No. 40 Lake.
f) FD&C Yellow No. 5. g) FD&C Yellow No. 5, FD&C Red No. 40, FD&C Blue No. 1. h) FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 40, FD&C Blue No. 1, FD&C Red No. 3, FD&C Blue No. 2 Lake, FD&C Yellow No. 6 Lake, and FD&C Red No. 40 Lake.
i) FD&C Yellow No. 5, FD&C Red No. 40, FD&C Blue No. 1. j) FD&C Yellow No. 5 and FD&C Blue No. 1.
k) Wheat flour, FD&C Yellow No. 5 Lake, FD&C Yellow No. 6 Lake, FD&C Red No. 3, FD&C Blue No. 1 Lake, and FD&C Blue No. 2 Lake.
l) FD&C Yellow No. 6.
m) Soybeans, wheat, milk, sesame seeds and FD&C Yellow No. 5.
n) Wheat, soybean, milk and sesame seeds.
________
PRODUCT
Hinode brand Harvest Blend, White & Wild Rices with Garden Vegetables, in 3.25-pound
plastic jars, 8 jars per case.
Recall #F-598-0.
CODE
S075100, S076100, S080100, S081100, and S072100.
MANFACTURER
Rice Growers Association of CA, West Sacramento, California.
RECALLED BY
Manufacturer, by letter and telephone. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
1,992 trays were distributed.
REASON
The product is contaminated with pieces of approximately 25 gauge wire ranging from
7-12 mm in length.
________
PRODUCT
FruitFresh Strawberry Squares, 5 pieces per clear plastic box, 7.1 ounces. Recall
#F-599-0.
CODE
All "Sell By" Dates.
MANFACTURER
Authentic Cookies, also known as Isack's Cookie Factory, Montreal, Quebec, Canada.
RECALLED BY
Save-A-Lot Ltd., Earth City, Montana, by letter dated April 12, 2000. Firm-initiated
recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
Firm estimates none remains on the market.
REASON
Product contained tartrazine, an uncertified color and amaranth, an unapproved color.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________
PRODUCT
King Oscar brand Rolled Fillets of Anchovies in Pure Olive Oil and Capers, packed in
2-ounce (56 g) tin cans.
Recall #F-560-0.
CODE
Can Code A0154D.
MANFACTURER
Ste. Sialco, Aqadir, Morocco.
RECALLED BY
Bumble Bee Seafood, Inc., San Diego, California, by letter dated March 7, 2000.
Ongoing recall resulted from sample analysis and follow-up by the State of Florida's
Department of Agriculture and Consumer Services of Tallahassee.
DISTRIBUTION
Michigan, Illinois, Indiana, Texas, Florida.
QUANTITY
2,080 cases were distributed.
REASON
Product is decomposed.
________
PRODUCT
Minute Maid Premium All Natural Citrus Punch with Added Calcium and Vitamin C, in 64-
ounce cartons.
Recall #F-574-0.
CODE
May 11 LE4/XXXX AAA
May 12 LE4/XXXX AAA
where XXXX is a four digit, May 11 and 12 represents
expiration dates and AAA is operator initials.
MANFACTURER
Cutrale Citrus Juices, USA, Leesburg, Florida.
RECALLED BY
Coca Cola Foods, Houston, Texas, by telephone on April 13, 2000, followed by visit.
Firm-initiated recall complete.
DISTRIBUTION
Southeastern United States.
QUANTITY
5,164 cases of 8 cartons each were distributed.
REASON
Product was contaminated with black particulate matter originating from a
disintegrated food-grade gasket.
________
PRODUCT
Various candies repacked by the recalling firm, sold in
1-pound clear plastic bags: a) Red Candied Cherries;
b) Cinnamon Bears. Recall #F-593/594-0.
CODE
None.
MANFACTURER
Premier Packing Company, Greenacres, Washington.
RECALLED BY
Manufacturer, by telephone on April 4, 2000, or by letter on April 21, 2000. Firm-
initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
Firm estimates none remains on the market.
REASON
Products contain undeclared FD&C Red No. 40.
CODE
Unit #1659179.
MANFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by letter dated May 18, 2000. Firm-initiated recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a unit collected from a donor who had taken aspirin
within 3 days of donation.
________
PRODUCT
Red Blood Cells. Recall #B-824-0.
CODE
Unit #7460679.
MANFACTURER
Carter Blood Center, Bedford, Texas.
RECALLED BY
Manufacturer, by telephone and fax on May 13, 1999. Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was mislabeled as CMV antibody negative.
________
PRODUCT
Corneas. Recall #B-825-0.
CODE
004-00-282, 004-00-283.
MANFACTURER
East Tennessee Lions Eye Bank, Knoxville, Tennessee.
RECALLED BY
Manufacturer, by letter dated May 9, 2000. Firm-initiated recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
2 units were distributed.
REASON
Corneas were collected from a donor who tested repeatedly reactive for the antibody
to the Hepatitis C virus.
________
PRODUCT
Red Blood Cells, Irradiated. Recall #B-826-0.
CODE
Unit #R31876.
MANFACTURER
HCSC Blood Center, trading as Miller Memorial Blood Center, Bethlehem, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on August 25, 1999. Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled as leukoreduced but did not undergo leukoreduction.
________
PRODUCT
Platelets. Recall #B-830-0.
CODE
Unit #32GF30389.
MANFACTURER
American Red Cross Blood Services, Green Bay, Wisconsin.
RECALLED BY
American Red Cross Blood Services, Madison, Wisconsin, by telephone on January 26,
1999. Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected in a manner that may have compromised the sterility of
the unit.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-831/833-
0.
CODE
Unit Numbers: a) 32GK68612, 32GK53661; b) 32GK68612;
c) 32GK53661.
MANFACTURER
American Red Cross Blood Services, Green Bay, Wisconsin.
RECALLED BY
American Red Cross Blood Services, Madison, Wisconsin, by letter dated December 10,
1999. Firm-initiated recall complete.
DISTRIBUTION
Illinois, Wisconsin, California.
QUANTITY
a) 2 units; b) 1 unit; c) 1 unit.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency
virus type (HIV), but were collected from a donor who previously tested repeatedly
reactive for the antibody, were distributed.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-852/853-0.
CODE
Unit #19GK35939.
MANFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letters on October 19, 1999, and November 1, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Illinois and Kentucky.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported travel to an area designated
as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells Leukoreduced.
Recall #B-856/857-0.
CODE
Unit #19LE16522; b) 19LF12412, 19GZ47918, 19GH30369.
MANFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated December 21, 1999. Firm-initiated recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
a) 1 unit; b) 3 units were distributed.
REASON
Blood products were collected from a donor who reported travel to an area designated
as endemic for malaria.
________
PRODUCT
Platelets, Pheresis. Recall #B-861-0.
CODE
Unit #04FP46685.
MANFACTURER
The American National Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by telephone on September 30, 1999, and by letter dated October 27,
1999. Firm-initiated recall complete.
DISTRIBUTION
West Virginia.
QUANTITY
1 unit was distributed.
REASON
Blood product tested negative for Cytomegalovirus (CMV), but was collected from a
donor who previously tested CMV positive.
Recall #B-821/822-0.
CODE
Unit Numbers: a) 20LC30077, 20LC30093, 20LC30096, 20LC30100, 20LC30101, 20LC30104,
20LC30105, 20LC30107, 20LC30109, 20LC30110, 20LY19473, 20LY19477, 20LY19478,
20LC30094, 20LC30102, 20LC30108
b) 20LC30074, 20LC30077, 20LC30080, 20LC30093, 20LC30104, 20LY19476, 20LY19477,
20LY19857.
MANFACTURER
American Red Cross, Boise, Idaho.
RECALLED BY
Manufacturer, by telephone on either April 16 or 21, 1999, followed by letter either
May 4 or 7, 1999. Firm-initiated recall complete.
DISTRIBUTION
Alabama, California, Idaho, Tennessee, Texas.
QUANTITY
a) 16 units; b) 8 units were distributed.
REASON
Blood products were processed in a centrifuge that was not set at the speed and time
specified in the manufacturing instructions.
________
PRODUCT
Platelets. Recall #B-862-0.
CODE
Unit #4927565.
MANFACTURER
New York Blood Center, Inc., New York, New York.
RECALLED BY
Manufacturer, by letter dated May 5, 2000. Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a unit of whole blood whose collection time could not
be determined.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
________
PRODUCT
Various kits/trays containing containing products recalled by Clinipad Corporation:
Peripherally Inserted Central Catheter; MLC SLI Peripherally Inserted Central; PAT
100 Port Access Tray; CISK B. Braun IV Start Kits; CGKM Guidewire Introducer Set;
CESKSD Continuous Epidural Anesthesia Tray; Spinocan Spinal Needle; Braun
Percutaneous Introducer Set; Burron Microcath Intra. Cath. Placement; Runyon Large
Volume Parcentesis Kit; Double Ended Vented Transfer Device; Dressing Change Tray;
Dressing Change Kits. Recall #Z-691-0.
CODE
(Note: If necessary, A complete list of devices, catalog and lot numbers can be
obtained from the Philadelphia District Office Recall Coordinator).
MANFACTURER
B. Braun Medical, Inc., Allentown, Pennsylvania.
RECALLED BY
Manufacturer, by letter on March 23, 2000, instructing the consignees to remove and
destroy the Clinipad components in the kit/trays. Firm-initiated recall ongoing.
COMPONENT
MANFACTURER
Clinipad Corporation, Charlotte, North Carolina.
DISTRIBUTION
Nationwide.
QUANTITY
921,000 units.
REASON
The products contain Clinipad products labeled as sterile for which Clinipad is
unable to assure sterility and/or contain Clinipad products not labeled as sterile
for which the company has no assurance that they meet microbiological release
specifications.
CODE
Lot Numbers: ANH000330, ANH000404, ANH000407, ANH000410 thru ANH000414, ANH000417
thru ANH000420.
MANFACTURER
Valleylab, Inc., Boulder, Colorado.
RECALLED BY
Manufacturer, by letter on April 12, 2000, and April 15, 2000. Firm-initiated recall
ongoing.
DISTRIBUTION
Alabama, Arizona, California, Colorado, Georgia, Hawaii, Illinois, Indiana,
Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York,
Oklahoma, Pennsylvania, Tennessee, Texas, Wyoming, Australia, Canada, France, Israel
and Lebanon.
QUANTITY
155 cases, 6 units per case were distributed.
REASON
Grasping ability of device may decrease and, with continued use, come apart.
________
PRODUCT
Bayer Advia 120 Automated Hemotology System, Model 120, a
quantitative automated hematology analyzer that provides a leukocyte, differential
count and reticulocyte analysis for in vitro diagnostic use in clinical laboratories.
Recall #Z-810-0.
CODE
All serial numbers.
MANFACTURER
Bayer Diagnostics Mfg. Ltd., Swords, Co. Dublin, Ireland.
RECALLED BY
Bayer Corporation, Elkhart, Indiana, by letter dated May 2000. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,800 units were distributed.
REASON
Higher than expected percentage Reticulocyte counts were received, due to carryover
from one sample to another.
________
PRODUCT
CyroValve Allograft Heart Valves. Recall #Z-813/815-0.
CODE
Serial No. - 3975614 - Model No. PV05,
Serial No. - 3979504 - Model No. AV00,
Serial No. - 3979512 - Model No. PV00,
Serial No. - 6160301 - Model No. AV00,
Serial No. - 6160328 - Model No. PV00.
MANFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter on May 17&18, 2000. Firm-initiated recall complete.
DISTRIBUTION
Utah, Florida, Michigan, Minnesota.
QUANTITY
5 valves were distributed.
REASON
Donor did not meet current guidelines for serodilution of plasma.
________
PRODUCT
CyroValve Heart Valve Allograft. Recall #Z-816-0.
CODE
Serial No. 4302801 - Model No. PV00.
MANFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter on May 22, 2000. Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 valve was distributed.
REASON
Allograft was collected from a donor who had been incarcerated.
________
PRODUCT
Howmedica Ostenonics System 12 Crossfire P4 10 polyethylene insert, Catalog number
6352-5-074. Recall #Z-818-0.
CODE
Case Code TC3021.
MANFACTURER
Howmedica Ostenonics Corp., Allendale, New Jersey.
RECALLED BY
Manufacturer, by letter, dated April 3, 2000, and faxed on April 4, 2000. Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
151 units were distributed.
REASON
Size improperly stamped.
________
PRODUCT
The Becton Dickinson (Bard Parker) ABG Kits, containing recalled Clinipad products.
Recall #Z-819-0.
CODE
Catalog Numbers 305089, 375280, 305306, 375310, 375315,
375320, 375325, 305326, 305342, 375381, 375385, 375392,
375395, 375410, 375420, 305421. (A complete list of devices, catalog and lot numbers
can be obtained from the New Jersey District Office Recall Coordinator).
MANFACTURER
Becton Dickinson & Company, Franklin Lakes, New Jersey.
RECALLED BY
Manufacturer, by recall communications dated April 17, 2000. Firm-initiated recall
ongoing.
COMPONENT
MANFACTURER
Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION
Nationwide.
QUANTITY
956,850 kits were distributed.
REASON
Kits contain Clinipad products labeled as sterile for which Clinipad is unable to
assure the sterility.
________
PRODUCT
Sterile Procedural Trays/Kits packaged by Orion Medical Products, Wheeling, IL; the
trays are packaged in cases of 10, 20, or 30 trays each under the Orion, Managed
Care, Rusch, Lifenet, ProMed, Grace, Manheim, Starline, and Intermed labels. Recall
#Z-820-0.
CODE
All Orion kit lot numbers shipped since 1/1/97 of the listed reorder numbers.
a) kits containing Alcohol Prep Pads, Medium, Cat. 0110B3
b) Kits containing Iodophor-PVP Povidone-Iodine 10% Swabsticks, cat. 12915-13
c) Kits containing Alcohol Prep Pads, Medium and Iodophor PVP
d) Kits containing Iodophor PVP Povidone Iodine 10% Solution, cat. 3944S-B
e) Kits containing Iodophor PVP Povidone Iodine 10% Swabsticks and Iodophor PVP Povidone Iodine 10% Ointment,
f) Kits containing Alcohol Prep Pads, Medium and Iodophor PVP Povidone Iodine 10% Swabsticks, cat. 0110B3 & 1291S-B.
(Note: A complete list of devices, catalog and lot numbers can be obtained from the Chicago District Office Recall Coordinator).
MANFACTURER
Orion Life Systems, Inc., Wheeling, Illinois.
RECALLED BY
Manufacturer, by letter dated March 22, 2000. Firm-initiated recall ongoing.
COMPONENT
MANFACTURER
Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION
Nationwide.
QUANTITY
70,000 cases were distributed.
REASON
Kits and trays contain Clinipad products labeled as sterile for which Clinipad is
unable to assure sterility.
________
PRODUCT
Abbott Plum XL Series Infusion Pumps, single and triple line infusion pumps utilizing
I.V. administration set cassettes. Recall #Z-821/826-0.
CODE
All serial numbers manufactured prior to 12/1/99 of the following list numbers.
11555-04, Plum XL Infusion Pump 11781-04, Plum XL3 Multi-Line Infusion Pump, 11845-04, Plum XL3 Micro/Macro Multi-Line Infusion Pump, 11846-04, Plum XL Micro/Macro Infusion Pump, 11855-04, Plum XL3 Micro/Macro Multi-Line Infusion Pump, w/Dataport, 11859-04, Plum XL Micro/Macro Infusion Pump w/Dataport.
MANFACTURER
Abbott Laboratories, Morgan Hills, California.
RECALLED BY
Abbott Laboratories, Hospital Products Division,
Abbott Park, Illinois, by Technical Service Bulletins dated February 2000, and by
letter dated May 26, 2000. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
81,159 pumps were distributed.
REASON
Increased number of cassette alarms.
________
PRODUCT
Atwater Carey Ltd. First Aid Kits having the following particular names identifying
the uses of the kits: Blister Doc, Pocket Doc, Travel Doc, Cycle Doc, Personal
(First Aid), Dayhiker, Backpacker, After The Fall, Walkabout, Family (First Aid),
International, Expedition, EMT First Aid, Mountain Rescue, 25 Person, EMT WMI, Sport
Pak, Whitewater, Pocket Watertight, Swiftwater Paddler, Wilderness Canoe, Marine Life
Pak, Athletes Kit, Athletes Replace Module, Coaches Kit, Coaches Replace Module,
Team, American Challenge Team, Team Replace Module, Wound Management Module, First
Aid Refill of Antiseptic Towelettes, First Aid Refill - Tincture of Benzoin, Blister
Kit, and Marine Waterproof. These kits are labeled as assembled by Wisconsin
Pharmacal, Inc., Jackson, WI;
Wilderness Medicine Pro 0.5, 1.0, 2.0, and 3.0 First Aid Systems. These first aid
kits have the firm name and address of Atwater Carey, Ltd., Salida, CO 81201 on the
labels.
The following private label first aid kits were included in the recall: Eagle Creek Traveler, Kwik Tek, Safeway 25 Person Refill, Campmor Hiker, Campmor Guide, and Campmor Advanced. Recall #Z-827-0.
CODE
Code Information: There are no lot numbers on the kits.
The kits have part numbers, as follows:
Atwater Carey Ltd. first aid kits: 153-156, 158-163, 165, 166, 168, 169, 171-173,
175, 177, 177CO, 178, 180-184, 182RM-184RM, 184AC, 208, 217, 220, 221, and 299.
Wilderness Medicine Pro first aid kits: 260-263 Eagle Creek Traveler Kits: 268 and 268C Kwik Tek Kit: 277; Safeway 25 Person Refill: 282 Campmor first aid kits: 294-296.
MANFACTURER
WPC Brands/Wisconsin Pharmacal Company, Jackson, Wisconsin.
RECALLED BY
Manufacturer, by letter dated March 28, 2000. Firm-initiated recall ongoing.
COMPONENT
MANFACTURER
Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION
Nationwide, Canada, Belgium.
QUANTITY
219,000 kits were distributed; firm estimated that 70,000 kits remained on market at
time of recall initiation.
REASON
Kits contain Clinipad products labeled as sterile for which Clinipad is unable to
assure the sterility.
________
PRODUCT
Medical Graphics Cart, Part #800192, used for diagnostic equipment for checking a
patient's pulmonary function, ECG, and other factors. Recall #Z-828-0.
CODE
Carts with "99" stamped in their bases with 8 dots arranged in a circle around the 99
are affected.
MANFACTURER
Medical Graphics Corporation, St. Paul, Minnesota.
RECALLED BY
Manufacturer, by product bulletin dated May 25, 2000. Firm-initiated field
correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
46 carts were distributed.
REASON
Base of cart could crack allowing caster to come off and cart to topple over.
________
PRODUCT
Replace/Steri-Oss brand of 4.3 mm Diameter Dental Healing Abutment. Recall #Z-831-
0.
CODE
Lot #307893, Part #61027, EXP 2/05.
MANFACTURER
Nobel Biocare USA, Inc., Yorba Linda, California.
RECALLED BY
Manufacturer, by letter on May 3, 2000. Firm-initiated recall ongoing.
DISTRIBUTION
California, Colorado, Connecticut, Florida, Idaho, Indiana, Michigan, Minnesota,
Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia,
Washington state.
QUANTITY
110 units were distributed.
REASON
The wrong size, 4.5 mm D x 3 mm H, endosseous dental implant (healing abutment) was
placed into the device packaging labeled for a 4.5 mm D x 5 mm H healing abutment.
________
PRODUCT
Anti-Needlestick Devices: a) B100L UltraSafe Needle Guard; b) CT200 UltraSafe
Injection System. Recall #Z-832/833-0.
CODE
Lot Numbers: a) 91601, 926701, 926702, 928701, 928702, 929401, 931902, 931903,
932601, 934301, 934401;
b) 927001, 92301, 930801, 930802, 930803, 933401, 933701, 936401, 000401.
MANFACTURER
Noved Medical, Chatsworth, California.
RECALLED BY
Safety Syringes, Inc., Carlsbad, California, by letter February 10, 2000. Firm-
initiated recall complete.
DISTRIBUTION
California.
QUANTITY
a) 32,200; b) 27,100 were distributed.
REASON
Products were misassembled during production, creating the potential for a needle
stick health risk.
________
PRODUCT
Transcutaneous Electrical Nerve Stimulators containing recalled Clinipad Sterile
Alcohol Wipes. Recall #Z-840-0.
.
CODE
Multiple lot numbers. (Note: If necessary, a complete list of lot numbers can be
obtained from the Los Angeles District Office Recall Coordinator).
MANFACTURER
Woodside Biomedical, Inc., Carlsbad, California.
RECALLED BY
Manufacturer, by letter on April 4, 2000. Firm-initiated recall complete.
COMPONENT
MANFACTURER
Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION
Nationwide.
QUANTITY
25,357 units were distributed.
REASON
Kits contained Clinipad products, labeled as sterile, which lacked assurance of
sterility.
__________
PRODUCT
Bard/Vas-Cath, Modified Vas-Cath Catheter Repair Kit, Catalog Number 5586000. Recall
#Z-841-0.
CODE
Lot Numbers 22AK1493, 22AK1495, 22LJX028.
MANFACTURER
Bard Access Systems, Inc., Salt Lake City, Utah.
RECALLED BY
Manufacturer, by letters mailed April 4-5, 2000. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Australia and Canada.
QUANTITY
1,008 units were distributed.
REASON
Catheter repair kit connector may detach from repaired catheter extension legs.
________
PRODUCT
a) VA Medical Center, Seattle Cardiac Pack; b) Lawrence Memorial Hospital
Pericardiocentesis Pack.
Recall #Z-846/847-0.
CODE
Lot Numbers M0899291, M0999201.
MANFACTURER
Cordis Corporation, Miami, Florida (component manufacturer/responsible firm).
RECALLED BY
Maxxim Medical, Inc., (formerly Cordis Medical Products), Asheville, North Carolina,
by telephone on May 5, 2000 and April 27, 2000. Firm-initiated recall ongoing.
DISTRIBUTION
Washington state, Kansas.
QUANTITY
a) 27 kits; b) 5 packs were distributed.
REASON
Kits/packs contain catheters recalled by Cordis Corporation for possible unexpected
fibers.
________
PRODUCT
Sorbic Acid Preserved Saline Solution, in 16-ounce bottles, under the following
labels: Fedco, Equate, London Drugs and Life. Recall #Z-849-0.
CODE
Lot Numbers 8J101, EXP 10/00; 9C091, EXP 3/01.
MANFACTURER
Optopics Laboratories Corporation, Fairton, New Jersey.
RECALLED BY
Manufacturer, by letter on April 14, 2000. Firm-initiated recall ongoing.
DISTRIBUTION
To direct wholesale accounts.
QUANTITY
10,500 bottles of Lot #8J101; 10,728 bottles of Lot #9C091 were distributed.
REASON
Lack of sterility assurance of Sorbic Acid Preserved saline.
_______
UPDATE
Several recalls which appeared in the June 28, 2000 Enforcement Report incorrectly
listed the manufacturer and recalling firm as the same. The following are the
correct manufacturers and recalling firms for the noted recalls:
Z-754/755-0 - SYSMEX CA-100 and SYSMEX CA-500 Automated Coagulation Analyzer
Manufacturer: Sysmex Corp., Kobe, Japan
Recalling Firm: Sysmex Corporation of America, Long Grove, IL
Z-785/789-0 - Sarita and Sarita 160 Patient Lift;
Z-790-0 - Maxilift Patient Lift;
Z-791/799-0 - Maximove Patient Lift;
Z-800/802-0 -Marisa Patient Lift
Manufacturer: Arjo Ltd., Glouster, UK
Recalling Firm: Arjo, Inc., Roselle, IL.
CODE
Lot Numbers 114, 114A, 115, and 116.
MANFACTURER
Diagnostic Products Corporation, Los Angeles, California.
RECALLED BY
Manufacturer, by telephone, fax or E-mail on April 20, 2000. Firm-initiated recall
ongoing.
DISTRIBUTION
Arizona, California, Colorado, Georgia, Indiana, Kansas, Massachusetts, Maine,
Missouri, New Jersey, New Mexico, New York, Pennsylvania, Rhode Island, South
Carolina, Washington, and international.
QUANTITY
845 units were distributed.
REASON
The product can yield falsely elevated test results.
________
PRODUCT
Zimmer NexGen Knee Option Femoral Size D, Right, Catalog 00-5996-0114-02. Recall #Z-
834-0.
CODE
Lot # 62813700.
MANFACTURER
Zimmer, Inc., Warsaw, Indiana.
RECALLED BY
Manufacturer, by letter on May 31, 2000. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
77 units were distributed.
REASON
The buffing residue was left affixed to the underside of the femoral knee component.
________
PRODUCT
Medtronic Midas Rex Disecting Tool:
(a) Medtronic Midas Rex Disecting Tool M-1;
(b) Medtronic Midas Rex Disecting Tool AM-3;
(c) Medtronic Midas Rex Disecting Tool S4-350
(d) Medtronic Midas Rex Disecting Tool S8-350.
Recall #Z-842/845-0.
CODE
Lot Numbers: (a) N3640, N4158, N4150, N4231, N4555, N4562; (b) O0645; (c) P0963; (d)
O4935.
MANFACTURER
Midas Rex, L.P., Fort Worth, Texas.
RECALLED BY
Manufacturer, by letter dated May 23, 2000. Firm-initiated recall complete.
DISTRIBUTION
Nationwide, Turkey, and Ireland.
QUANTITY
290 units were distributed.
REASON
The head of the tool may separate during use.
________
PRODUCT
Binax now Legionella Urinary Antigen Text 22 Kit, for the rapid detection of
Legionella pneumophilia seogroup 1 antigen. Recall # Z-848-0.
CODE
Lot #002644B, EXP 14 JUN 01.
MANFACTURER
Binax, Inc., Portland, Maine.
RECALLED BY
Manufacturer, by letter mailed on June 16, 2000. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Switzerland.
QUANTITY
99 kits were distributed.
REASON
Product has an extended expiration date.
________
UPDATE
Several recalls which appeared in the June 28, 2000 Enforcement Report incorrectly
listed the manufacturer and recalling firm as the same. The following is the correct
manufacturer and recalling firm for the noted recall:
Z-762-0 - Pentalumen Thermodilution Catheter, Heparin Coated:
Manufacturer: Abbott Laboratories, Salt Lake City, UT
Recalling Firm: Abbott Laboratories, Abbott Park, IL.
END OF ENFORCEMENT REPORT FOR JULY 5, 2000.
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Hypertext uploaded by clb 2000-JUL-05.