October 8, 2003
03-41
_______________________________
PRODUCT
Robinson Crusoe Smoked Atlantic Salmon packaged in 6 5/8 oz. cans. Product of Chile. Recall # F-557-3.
CODE
The following codes are found on the bottom of cans: 051101, 081101, 051201, 160202, 080801, 220602, 041002 and 181002.
RECALLING FIRM/MANUFACTURER
Hispamer Distributors, Miami, FL, by letter on June 6, 2003, and by visit from June 6, 2003 to June 13, 2003. Firm initiated recall is complete.
REASON
The product did not receive an adequate thermal process to eliminate pathogens of public health concern, including Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
5,160 cans.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Vanilla flavored soy milk. Recall # F-561-3.
CODE
JUNE 17 03 H CD-70, JUNE 17 03 J CD-70, JUNE 18 03 H CD-70,
JUNE 18 03 J CD-70, JUNE 27 03 H CD-70, JUNE 27 03 J CD-70.
RECALLING FIRM/MANUFACTURER
White Wave, Inc., Boulder, CO, by telephone, e-mail or fax on April 16, 2003. Firm initiated recall is complete.
REASON
Soy milk may be contaminated with a caustic sodium hydroxide based sanitizer.
VOLUME OF PRODUCT IN COMMERCE
Approx. 138,480 half gallon units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Marshall's Flavor House brand EGG Shade Power in 1 pound
case. Recall # F-562-1;
b) Marshall's Flavor House brand Artifical Egg Shade Color
(liquid) in 1 pound case. Recall # F-563-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Marshall's Flavor House, Inc., Richmond, CA, by letters on June 3, 2003. FDA initiated recall is complete.
REASON
Products contain undeclared FD&C colors, Yellow #5, Yellow #6, and Red #40.
VOLUME OF PRODUCT IN COMMERCE
482 quarts.
DISTRIBUTION
CA and AL.
_______________________________
PRODUCT
a) MELO-D Lemon-Lime Slush Flavor, 4/1-gallon jugs per
case. Labeled in part, "MELO-D Slush Flavors. Contents
128 Fl. Ox. (1 gal)." Recall # F-564-3.
b) Danny's Delicious Snow -Kone Imitation Lime Flavored
Syrup, 4/1-gallon jugs per case. Recall # F-565-2.
CODE
a) Lot #052903;
b) Lots: #082903, #071503.
RECALLING FIRM/MANUFACTURER
M&B Fruit Juice Products, Co., Akron, OH, by telephone on September 11, 2003 and letter on September 9, 12, 15, and 16, 2003. FDA initiated recall is ongoing.
REASON
The products contain undeclared FD&C colors, Yellow No 5 and Blue #1.
VOLUME OF PRODUCT IN COMMERCE
61 cases.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Banzai brand sushi products (6 oz. to 9 oz.):
a) California Roll. Recall # F-566-3;
b) Seattle Roll. Recall # F-567-3;
c) Mt. Fuji Crab Roll. Recall # F-568-3;
d) Spicy Tuna Roll. Recall # F-569-3;
e) Pacific Shrimp Roll. Recall # F-570-3;
f) Smoked Salmon Roll. Recall # F-571-3;
g) Unagi Roll. Recall # F-572-3;
h) Inari Sushi. Recall # F-573-3;
i) Tekka Maki Sushi. Recall # F-574-3;
j) Kappa Maki Sushi. Recall # F-575-3;
k) California & Seattle Roll. Recall # F-576-3;
l) California & Inari Sushi. Recall # F-577-3;
m) Nigiri Variety. Recall # F-578-3;
n) Nigiri & California Roll. Recall # F-579-3;
o) Vegetarian Roll. Recall #F-580-3;
p) Futomaki & Inari Sushi. Recall # F581-3;
q) Futomaki & California Roll. Recall # F-582-3.
CODE
CONSUME BY AUG 14 and before.
RECALLING FIRM/MANUFACTURER
Entrees, Inc., Seattle, WA, by telephone on August 13, 2003, and by letter dated August 14, 2003.
REASON
Product contains undeclared FD&C color, Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
1,889.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Powerpuff Girls Kit containing Pink Lotion Base 2 fl. Oz. packaged in a clear plastic zip pillow pak identified as (item #120-9334). Catalog Item # 110-8294. Recall # F-583-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Delta Education, Nashua, NH, by telephone on February 21, 2003, and by letter on March 26, 2003. Firm initiated recall is complete.
REASON
Pink lotion is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
60,290 kits.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
FUL-FLAV-R brand Diced Sweet Red Peppers in 6 lbs. 6 oz. can. Product of Mexico. Recall # F-554-3.
CODE
101, UPC Code: 7 8454 10101 3, Lot #: APR04/RB291.
RECALLING FIRM/MANUFACTURER
Ful Flav-R Foods Products, Inc., Oakland, CA, by letters on January 16, 2003. Firm initiated recall is complete.
REASON
Product is unfit for food due to spoilage and swollen cans.
VOLUME OF PRODUCT IN COMMERCE
700 cases.
DISTRIBUTION
CA, UT and OR.
_______________________________
PRODUCT
Corneas. Recall # B-1745-3.
CODE
Tissue numbers 0203-0179-OS and 0203-0179-OD.
RECALLING FIRM/MANUFACTURER
Old Dominion Eye Foundation, Inc., Richmond, VA, by telephone on September 18, 2002. Firm initiated recall is complete.
REASON
Corneas, not tested for infectious disease markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Cryoprecititated AHF. Recall # B-1754-3.
CODE
J36519, J36521, J36523, J36524, J36525, J36526, J36531, J36535, J36536, J36541, J36542, J36543, J36545, J36549, J36552, J36560, J36563, J36566, J36567, J36569, J36580, J36583, J36588, J36590, J36601, J36607, J36608, J36609, J36620, J36621, J36633, J36638, J36641, J36647, J36660, J36665, J36666, J36679, J36684, J36686, J36696, J36698, J36699, J36700, J36726, J36732, J36733, J36735, J36740, J36745, J36748, J36752, J36753, J36754, J36757, J36758, J36771, J36775, J36786, J36798, J36799, J36806, J36809, J36810, J36816, J36819, J36820, J36821, J36825, J36828, J36830, J36854, J36861, J36862, J36887, J36903, J37355, J37940, J37951, J37955, J37962, J37963, J37964, J44442, J37974, J39497.
RECALLING FIRM/MANUFACTURER
Regional Health Resource Center, Urbana, IL, by letter dated December 10, 2002 and August 8, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured without quality control performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
86 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1804-3.
CODE
1273829, 2767574, 3963308, 1275371, 3957191, 3963311, 1275442, 3957944, 3963313, 1277192, 3958949, 3963314, 2746980, 3959084, 3963322, 2752011, 3959140, 3963336, 2756329, 3959176, 3964509, 2757442, 3959720, 3965417, 2758836, 3960287, 6000333 2763684, 3963290, 2764133A, 3963293, 2764133B, 3963294, 2765033, 3963297, 2766738, 3963298, 2767252, 3963302.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by letter dated July 2, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells Deglycerolized. Recall # B01820-3.
CODE
Unit 22LW55981.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Philadelphia, PA, by telephone on April 30, 2003 and by letter dated May 1, 2003. Firm initiated recall is complete.
REASON
Blood product, which tested positive for the S-antigen but was labeled as S-antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1822-3.
CODE
27FS15594.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by letter dated February 6, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not answer the questions related to ever having Chagas' disease or Babesiosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1823-3.
CODE
Unit 8404640.
RECALLING FIRM/MANUFACTURER
Texoma Regional Blood Center, Sherman, TX , by telephone on April 8, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking Lanoxin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Source Plasma. Recall # B-1826-3.
CODE
WSN002761, WSN002772.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile dated September 10, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been previously deferred at another center, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1827-3.
CODE
Unit number 1612686.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, Inc., East Orange, NJ , by telephone on March 17, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Platelets Pheresis, Leukocuytes Reduced. Recall # B-1828-3.
CODE
Unit number 1466502 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on September 18, 2001 and by letter on September 21, 2001. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1829-3.
CODE
Unit number 1664720.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on September 18, 2003 and by letter on September 21, 2001. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # 1830-3.
b) Platelets Leukocytes Reduced. Recall # B-1831-3.
CODE
a) and b) unit numbers 0924426 and 08937730.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH., by letter on April 29, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Source Plasma. Recall # B-1832-3.
CODE
Unit numbers 7030118179, 7030117744, 7030117605, 7030117201, 7030116841, 7030116494, 7030116243, 7030115951, 7030115757, 7030115159, 7030114940, 7030141125, 7030140627, 7030135278, 7030135065, 7030134298, 7030133925, 7030133222, 7030132924, 7030132234, 7030127481, 7030127178, 7030126682, 7030126403, 7030125866, 7030125659, 7030125055, 7030124784, 7030124202, 7030123926, 7030123175, 7030122434, 7030122266, 7030121703, 7030121560, 7030121033, 7030120913, 7030120432, 7030120356, 7030119807, 7030119598, 7030119116, 7030118946, and 7030118347.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX, by facsimile on October 17, 2000, and April 17, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
44 units.
DISTRIBUTION
NY and the United Kingdom.
_______________________________
PRODUCT
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number 30101. Recall # Z-1209-03.
CODE
Lot Numbers 040212-0, 040218-0 Expiration date 2/2004.
RECALLING FIRM/MANUFACTURER
BioMerieux, Durham, NC, by letter on August 6, 2003. Firm initiated recall is ongoing.
REASON
Product's decrease in sensitivity may result in false negative results.
VOLUME OF PRODUCT IN COMMERCE
2,204.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Disetronic H-TRON V100 Insulin Pump, catalog # 8010030C
(clear case) and 8010030 (solid-color case).
Recall # Z-1196-03;
b) Disetronic H-TRONplus Insulin Pump, catalog # 8050023
(clear case), 8050064 (blue case), 8050021 (solid-
color case) and 8050071 (yellow case).
Recall # Z-1197-0.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letter dated July 16, 2003. FDA initiated recall is ongoing.
REASON
Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
VOLUME OF PRODUCT IN COMMERCE
2,082.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Disetronic D-TRONplus Insulin Pump. Recall # Z-1198-03.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letter dated July 24, 2003. FDA initiated recall is ongoing.
REASON
Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.
VOLUME OF PRODUCT IN COMMERCE
8,000.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Bard PEG Safety System "Guidewire" Reorder Number
000930. Recall # Z-1230-03;
b) Bard Ponsky PEG Safety System "Pull" Reorder Number
001925. Recall # Z-1231-03;
c) Bard Ponsky PEG Safety System "Pull" Reorder Number
001927. Recall # Z-1232-03;
d) Bard PEG Safety System "Guidewire" Reorder Number
001928. Recall # Z-1233-03.
CODE
a) Lot Number 43FNA080, 43FNA081, 43FNA179;
b) Lot Number 43FNA086;
c) Lot Number 43FNA088;
d) Lot Number 43FNA090.
RECALLING FIRM/MANUFACTURER
Bard Endoscopic Technologies, Billerica, MA, by Recall Notice on August 4, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled kit: Prefilled Lidocaine syringe is labeled "sterile fluid path only", outer label states kit content is sterile.
VOLUME OF PRODUCT IN COMMERCE
538 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305. Recall # Z-1235-03.
CODE
Lot Number JCQ3141 Expiration Date: May 2004.
RECALLING FIRM/MANUFACTURER
Blue Torch Medical Technologies, Ashland, MA, by fax on July 10, 2003. Firm initiated recall is complete.
REASON
Products sterility is compromised due to a failed sterility audit.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
NY and TX.
____________________________
PRODUCT
Calculator/Data Processing Module for Clinical Use. Recall # Z-1240-03.
CODE
Verison 5.3 through 5.3.2.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on July 23, 2003. Firm initiated recall is ongoing.
REASON
Software Defect.
VOLUME OF PRODUCT IN COMMERCE
466.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs). Recall # Z-1243-03.
CODE
Serial Numbers: 50139962-2, 50128299-4, 50139968-5, 50139963-5, 50116580-5, 50128299-5, 50139964-2, 50139962-1, 50139971-2, 50139968-1, 50139964-3, 50128295-2, 50139964-1, 50139968-2, 50139964-4, 50128299-3, 50116576-2, 50128299-2, 50139968-3, 50139963-2, , 50139968-4, 50139963-4, 114766-1,114766-2.
RECALLING FIRM/MANUFACTURER
The Anspach Effort, Inc., Palm Beach Gardens, FL., by letter and fax on April 23, 2003. Firm initiated recall is complete.
REASON
Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
VOLUME OF PRODUCT IN COMMERCE
24.
DISTRIBUTION
FL, GA, NC, TX, CA, MA and MS.
_______________________________
PRODUCT
Disetronic Dahedi insulin infusion pump; catalog # 8500019. Recall # Z-1244-03.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated 8/5/03. FDA initiated recall is ongoing.
REASON
Lack of assurance of reliability.
VOLUME OF PRODUCT IN COMMERCE
296.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) ETHICON brand surgical device. The product described on
label is a Stapler, reload, TR35W, TR776, TCR 75, TCR
55, TRT75. Recall #Z-1257-03;
b) ETHICON brand surgical device. The product described on
label is a: 5mm Curved Shears, Scissors Grip Handle 14cm
Item Code CS14C. Recall # Z-1258-03;
c) ETHICON brand surgical device. The product described on
label is a: Reloads for Devices EZ45, ET45, NK45 Thick
Tissue, item ZR45G. Recall # Z-1259-03;
d) ETHICON brand surgical device. The product described on
label is a: Linear Cutter, Thick tissue 75 mm, item code
TCT75. Recall # Z-1260-03;
e) ETHICON brand surgical device. The product described on
label is a: Cutter, Linear 55mm and 75mm, item numbers
TCT75 and TLC55. Recall # Z-1261-03;
f) ETHICON brand surgical device The product described on
label is a: Laparosonic coagulating curved Pistal grip 5
mm, curved, Item Number LCSC5. Recall # Z-1262-03;
g) ETHICON brand surgical device. The product described on
label is a: Blade, 5 mm Curved Harmonic, item HC325.
Recall # Z-1263-03;
h) ETHICON brand surgical device. The product described on
label is a: Stapler EMS Endo Hernia , item # 8034.
Recall # Z-1264-03;
i) ETHICON brand surgical device. The product described on
label is a: TX Stapler, Reloadable, Linear 30 mm and 60
mm, item numbers TX30 and TX60. Recall # Z-1265-03;
j) ETHICON brand surgical device. The product described on
label is a: Stapler, Posered LDS Single Use, item #
092001. Recall # Z-1266-03;
k) ETHICON brand surgical device The product described on
label is a: Stapler, Articulating, Linear, item # AX55.
Recall # Z-1267-03;
l) ETHICON brand surgical device The product described on
label is a: Trocar, Dilating Tip, 10/12 mm, 100 length
w/stability sleeve, Item # 512SD. Recall # Z-1268-03;
m) ETHICON brand surgical device. The product described on
label is a: Trocar, Tristar, blunt tip, item 512B.
Recall # Z-Z-1369-03;
n) ETHICON brand surgical device. The product described on
label is a: Scissors, curved with unipola 5 mm. Recall
# Z-1370-03;
o) ETHICON brand surgical device The product described on
label is a: Shears, Coagulating, item CS150. Recall #
Z-1271-03;
p) ETHICON brand surgical device. The product described on
label is a: Cutter, ETS Endoscopic Linear, 35 mm, item #
TSB 35. Recall # Z-1272-03;
q) ETHICON brand surgical device. The product described on
label is a: Clip Applier, Multiple MCA, 20 clips 9 3/8
inch, item # MCS 20. Recall #Z-1273-03;
r) ETHICON brand surgical device. The product described on
label is a: Hook, Dissecting Harmonic Scalpel Blade 10
cm., item # DH105. Recall # Z-1274-03;
s) ETHICON brand surgical device The product described on
label is a: Needle, 120 mm, Pneumopcritoneum, item #
PN120. Recall # Z-1275-03;
t) ETHICON brand surgical device. The product described on
label is a: Thoracic Trocar Sleeve, rounded tip, Item #
TT012. Recall #Z-1276-03;
u) ETHICON brand surgical device. The product described on
label is a: Cutter, Linear Vascular, Item # TSB-35.
Recall # Z-1277-03;
v) ETHICON brand surgical device. The product described on
label is a: Needle, Ultra Veress. Recall # Z-1278-03.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Surgical Supply, Inc., Miami, FL, by e-mail on September 3, 2003.
Manufacturer: MedSurg Solutions, Plymouth, MN. FDA initiated recall is ongoing.
REASON
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
VOLUME OF PRODUCT IN COMMERCE
1,355.
DISTRIBUTION
MN and TN.
_______________________________
PRODUCT
a) Microflow Needles, catalog #DP8200, with 0 degree
tapering, labeled in part ***Non-sterile, Manufactured
for Bausch and Lomb, Inc. Rochester, NY 14609***,
packaged 6 needles/box. Recall # Z-1279-03;
b) Phaco Needles, catalog #DP8115, with 15 degree needle
taper, labeld in part***Non-sterile, Manufactured for
Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6
needles/box. Recall # Z-1280-03.
CODE
a) and b) Julian date coded "2003163".
RECALLING FIRM/MANUFACTURER
Bausch & Lomb, Incorporated, Lynchburg, VA, by telephone and letter on August 25, 2003. Firm initiated recall is ongoing.
REASON
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
VOLUME OF PRODUCT IN COMMERCE
66 packs.
DISTRIBUTION
FL, IA, WI, MA, IL and Internationally.
_______________________________
PRODUCT
a) Stanmore modular hip system; Stanmore CoCr femoral size
1 std. Stem; part 164241. Recall # Z-1281-03;
b) Stanmore modular hip system; Stanmore CoCr femoral size
2 std. stem; part 164242. Recall # Z-1282-03;
c) Stanmore modular hip system; Stanmore CoCr femoral size
3 std. stem; part 164243. Recall # Z-1283-03;
d) Stanmore modular hip system; Stanmore CoCr femoral size
4 std. stem; part 164244. Recall # Z-1284-03;
e) Stanmore modular hip system; Stanmore CoCr femoral size
5 std. stem; part 164245. Recall # Z-1285-03;
f) Stanmore modular hip system; Stanmore CoCr femoral size
1 straight stem; part 164251. Recall # Z-1286-03;
g) Stanmore modular hip system; Stanmore CoCr femoral size
2 straight stem; part 164252. Recall # Z-1287-03;
h) Stanmore modular hip system; Stanmore CoCr femoral size
3 straight stem; part 164253.Recall # Z-1288-03;
i) Stanmore modular hip system; Stanmore CoCr femoral size
4 straight stem; part 164254. Recall # Z-1289-03;
j) Stanmore modular hip system; Stanmore CoCr femoral size
5 straight stem; part 164255. Recall # Z-1290-03.
CODE
a) Lots 323846, 342260, 352799, 377954, 404867, 434003,
442086, 442087, 442088, 448410, 469963, 469966;
b) Lots 382010, 402898, 447968, 453654, 490929;
c) Lots 293564, 379905, 381377, 382015, 393047, 425146,
426418, 470412, 470438, 471933;
d) Lots 255928, 269737, 300486, 326364, 331233, 349386,
378840, 381381, 386128, 389269, 389270, 422994, 429482,
429483, 429484, 429485, 429488, 429558, 445460, 449848,
449850, 449853, 449854;
e) Lots 197284, 211992, 211998, 225646, 226431, 233479,
233677, 251871, 255929, 266786, 269741, 279430, 286358,
292600, 292735, 326453, 336746;
f) Lots 267824, 292736, 336747, 348666, 351182, 351944,
358183, 361071, 366677, 375324, 376152, 396782, 424534,
424535, 438547, 469956, 497678, 095912;
g) lots 251875, 264803, 372966, 378842, 379914, 419755,
432703, 432704, 432706, 491077, 491081;
h) 230240, 267147, 286360, 299075, 322326, 336749, 336750,
353706, 375330, 376153, 377974, 381383, 384128, 386132,
430623, 430624, 431204, 432709, 447474, 449861, 506390;
i) Lots 233483, 233678, 247053, 257714, 266787, 267829,
284743, 299077, 325372, 336751, 356108, 366679, 377975,
381384, 389272, 426130, 431582, 434005, 458470, 469949,
492412, 503981, 505220;
j) Lots 216219, 225643, 226963, 245624, 251876, 257715,
269754, 275019, 288843, 325373, 336752, 365220, 378844.
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter on June 18, 2003. Firm initiated recall is complete.
REASON
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
VOLUME OF PRODUCT IN COMMERCE
231.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
GE Medical Systems Corometrics Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is. Recall # Z-1291-03.
CODE
All serial numbers are involved.
RECALLING FIRM/MANUFACTURER
GE Medical Systems Information Technologies, Tampa, FL, by letter and telephone on May 14, 2003. Firm initiated recall is ongoing.
REASON
The 2120 Main Board on device lacks required external safety "watchdog" circuit.
VOLUME OF PRODUCT IN COMMERCE
170.
DISTRIBUTION
SC, WI, CA, MN, TX, MD, NV and France.
_______________________________
PRODUCT
a) Three Dog Bakery, The Bakery for Dogs, All Natural with
added vitamins and minerals, entree for dogs, 100
complete and nutritious, chicken, carrots, green beans
and rice recipe, ultra premium, net wt. 12 oz. (340G),
Distributed by Three Dog Bakery, Kansas City, MO.
Product of USA. The product is packed in laminated
flexible pouches. Recall # V-276-3;
b) Three Dog Bakery, The Bakery for Dogs, All Natural with
added vitamins and minerals, entree for dogs, 100
complete and nutritious, chicken, potatoes, carrots,
and rice recipe, ultra premium, net wt. 12 oz. (340G),
Distributed by Three Dog Bakery, Kansas City, MO.
Product of USA. The product is packed in laminated
flexible pouches. Recall # V-277-3;
c) Three Dog Bakery, The Bakery for Dogs, All Natural with
added vitamins and minerals, entree for dogs, 100
complete and nutritious, chicken, vegetables and rice
recipe, ultra premium, net wt. 12 oz. (340G),
Distributed by Three Dog Bakery, Kansas City, MO.
Product of USA. The product is packed in laminated
flexible pouches. Recall # V-278-3;
d) Three Dog Bakery, The Bakery for Dogs, All Natural with
added vitamins and minerals, entree for dogs, 100
complete and nutritious, smoked flavored chicken,
vegetables and rice recipe, ultra premium, net wt. 12
oz. (340G). Distributed by Three Dog Bakery, Kansas
City, MO. Product of USA. The product is packed in
laminated flexible pouches. Recall # V-279-3.
CODE
TDB DDM FOODS (any alpha numberic code).
RECALLING FIRM/MANUFACTURER
DDM Foods, Inc., Simpsonville, SC, via email, fax and telephone on May 2, 2003. Firm initiated recall is ongoing.
REASON
Swollen and leaking pouches due to poor seals.
VOLUME OF PRODUCT IN COMMERCE
61,000 pouches.
DISTRIBUTION
MO.
_______________________________
PRODUCT
a) Pig-Net Starter 2 (C400/T35)(WB) Medicated, product
#7092D, containing 400 g/ton chlortetracycline and 35
g/ton tiamulin hydrogen fumarate, packaged in 50-lb.
bags. The label shows Cargill Animal Nutrition,
Minneapolis, MN, as the responsible firm.
Recall # V-280-3;
b) Pig-Net Starter 3 (C400/T35)(WB) Medicated, product
#7093D, containing 400 g/ton chlortetracycline and 35
g/ton tiamulin hydrogen fumarate, packaged in 50-lb.
bags. The label shows Cargill Animal Nutrition,
Minneapolis, MN, as the responsible firm.
Recall # V-281-3;
c) Pig-Net Starter Pack(WB) prpduct #7094, packaged in 50-
lb. bags. The label shows Cargill Animal Nutrition,
Minneapolis, MN, as the responsible firm.
Recall # V-282-3;
d) Walnut Grove Swine Pre-Mix 22-11 (AL15)(WB), product
#71240T, packaged in 50-lb. bags. The label shows
Cargill Animal Nutrition, Minneapolis, MN, as the
responsible firm. Recall # V-283-3;
e) Cargill Animal Nutrition Pork Focus Swine Pre-Mix 22-11
(AL25) (WB), product #71240N, packaged in 50-lb, bags.
Recall # V-284-3;
f) Cargill Animal Nutrition Pork Focus 2.10 Pre-STR Diet
(C400/T35)(WB) Medicated, product #99222D, containing
400 g/ton chlortetracycline and 35 g/ton tiamulin
hydrogen fumarate, packaged in 50-lb. bags.
Recall # V-285-3;
g) Cargill Animal Nutrition Pork Focus Basemix 20-10 (WB),
product #99227, packaged in 50-lb, bags.
Recall # V-286-3;
h) Cargill Animal Nutrition Pork Focus Basemix Plain (WB),
product #99228, packaged in 50-lb, bags.
Recall # V-287-3;
i) Cargill Animal Nutrition Pork Focus Basemix 22-11 (WB),
product #99229, packaged in 50-lb, bags.
Recall # V-288-3;
j) Cargill Animal Nutrition Pork Focus 2.21 Starter Diet
(C400/T35)(WB) Medicated, product #99230D, containing
400 g/ton chlortetracycline and 35 g/ton tiamulin
hydrogen furnarate, packaged in 50-lb, bags.
Recall # V-289-3;
k) Cargill Animal Nutrition Pork Focus 2.22 Starter Diet
(MCX)(WB), Medicated, product #99234M, containing 50
g/ton carbadox, packaged in 50-lb, bags.
Recall # V-290-3;
l) Cargill Animal Nutrition Pork Focus 2.20 Starter Base
Mix (WB), product #99248, packaged in 50-lb, bags.
Recall # V-291-3;
m) Cargill Animal Nutrition Pork Focus 2.20 Starter
Essentials (WB), product #99250, packaged in 50-lb,
bags. Recall # V-292-3;
n) Pig Net Starter 2 W/363G Pulmotil, product #7092X,
containing 363 g/ton tilmicosin, packaged in 50-lb,
bags. Recall # V-293-3;
o) CAN Pork Focus 2.22 STR CTC/DEN, product #99234,
containing 35 g/ton tiamulin and 400 g/ton
chlortetracycline, packaged in 50-lb. bags.
Recall # V-294-3.
CODE
a) 316;
b) 304 and 323;
c) 296, 319, and 323;
d) and e) 302;
f) 317 and 323;
g) 298;
h) 305 and 322;
i) 294, 309, 312 and 317;
j) 304, 309 and 323;
k) 294;
l) 291;
m) 310 and 318;
n) 316;
0) 294.
RECALLING FIRM/MANUFACTURER
Cargill, Inc., Animal Nutrition, West Branch, IA, by telephone on May 6, 2003. FDA initiated recall is complete.
REASON
Firm received raw material ingredient zinc oxide from a supplier and it contained elevated levels of dioxin.
VOLUME OF PRODUCT IN COMMERCE
6,471/50-lb. bags.
DISTRIBUTION
IL and IA.
_______________________________
PRODUCT
Steamed bone meal under the following labels:
1) Upco Steamed Bone Meal for Dogs, Cats, and Horses, packaged in 1-lb. laminated pouches. 2) Benepet Steamed Bone Meal for Dogs, Cats, and Horses, packaged in a 1-lb. plastic jar. Recall # V-295-3.
CODE
Upco brand: 010584, 012214, 012431,020672, 021124, 021834, 030616, 030901, 031293, 031301, 031401, 031981, 032382, 032626, 033136, 040171, 041316, 051635, 051991, 052320, 060505, 061115, 061783, 071006, 072328, 080212, 080826, 081621, 082217, 082274, 082683, 083095, 092381, 101613, 102772, 111087, 111201, 111694, 112112.
Benepet brand: 011004, 012435, 021191, 021374, 022111, 032203, 032821, 041432, 042611, 051181, 051992, 060371, 061129, 061203, 080816, 081185, 082802, 090422, 092295, 111202, 120572, 120612.
RECALLING FIRM/MANUFACTURER
Ameri-Pac, Inc., St. Joseph, MO, via telephone on June 27, 2003 and by letter dated July 24, 2003. FDA initiated recall is complete.
REASON
Label lacks the cautionary statement "Do Not Feed to Cattle or Other Ruminants."
VOLUME OF PRODUCT IN COMMERCE
23.3 tons Upco brand and 6.7 tons Benepet brand.
DISTRIBUTION
MO.
_______________________________
PRODUCT
a) Frontier Feeds Pro-Line Sow, Swine Base Mix, packaged in
50-lb. bags or bulk. Recall # V-296-3;
b) Frontier Feeds Pro-Line-Bulk, Swine Base Mix, packaged
in 50-lb. bags or bulk. Recall # V-297-3;
c) Frontier Feeds Beef Finisher 1804, Cattle Feedlot
Mineral, packaged in 50-lb. bags. Recall # V-298-3;
d) Frontier Feeds 40% Beef Balancer B600 Cattle
Concentrate, containing 600 gm/ton lasalocid, packaged
in 50-lb. bags and bulk. Recall # V-299-3;
e) G & A Farms 32 % Protein Beef Calf Starter/Grower
Concentrate with Lasalocid, Medicated, containing 600
g/ton lasalocid. Recall # V-300-3.
CODE
Products purchased between 8/1/02-3/1/03.
RECALLING FIRM/MANUFACTURER
Frontier Feeds Company, Monticello, IA, by visits beginning approximately May 9, 2003. FDA initiated recall is complete.
REASON
Firm received raw material ingredient zinc oxide from a supplier that contained elevated levels of dioxin.
VOLUME OF PRODUCT IN COMMERCE
2,040/50-lb. bags +83.285 tons bulk.
DISTRIBUTION
IA.
_______________________________
PRODUCT
a) Frontier Feeds Pro-Line Sow, Swine Base Mix, packaged in
50-lb. bags or bulk. American Natural Soy Processors
Mega-Boost, packaged in 50-lb. bags, product #1850.
Recall # V-301-3;
b) American Natural Soy Processors Mega-Ton II, packaged in
50 lb. bags or bulk, product #1525. Recall # V-302-3;
CODE
Purchased between 1/1/02-12/31/02.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Natural Soy Processors LLC, Cherokee, IA, by telephone on May 330, 2003.
Manufacturer: American Natural Soy Processors, Hartley, IA. FDA initiated recall is complete.
REASON
Firm received raw material ingredient zinc oxide from a supplier that contained elevated levels of dioxin.
VOLUME OF PRODUCT IN COMMERCE
25.60 tons.
DISTRIBUTION
IA.
_______________________________
PRODUCT
Iverhart Plus (ivermectin/pyrantel) Flavored Chewables up to 25 pounds (Small). Each flavored chewable contains 68mcg ivermectin and 57 mg pyrantel as pamoate salt. Recall # V-303-3.
CODE
Lot number 002260.
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc, Forth Worth, TX, by letters on August 6, 2003 and August 7, 2003. Firm initiated recall is ongoing.
REASON
The lot tested sub-potent during stability testing.
VOLUME OF PRODUCT IN COMMERCE
470,820 tablets.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) MPP Super Pig Starter A, Medicated, a complete feed for
starter swine, containing 50 g/ton (0.0055%) carbadox,
product # 331, packaged in 50-lb. bags. Recall #V-304-3;
b) MPP Super Pig Starter B, Medicated, containing 50 g/ton
carbadox, product #337, bulk and packaged in 50-lb.
bags. Recall # V-305-3;
c) MPP Super Pig Starter C, Medicated, containing 50 g/ton
carbadox, product #342, bulk and packaged in 50-lb.
bags. Recall # V-306-3;
d) MPP Super Pig Starter D, Medicated, containing 100 g/ton
oxytetracycline and 200 g/ton neomycin sulfate, product
#347, packaged in 50-lb. bags. Recall # V-307-3;
e) MPP Super Pig Starter Premix, product #360, bulk
and packaged in 50-lb. bags. Recall # V-308-3;
f) Prestart 650 Base, packaged in 50-lb. bags.
Recall # V-309-3;
g) MPP Super Pig Starter B, product #336, packaged in 50-
lb. bags. Recall # V-310-3;
h) MPP Super Pig Starter B, Medicated, containing 35 g/ton
tiamulin hydrogen fumarate and 400 g/ton
chlortetracycline, product #338. Recall # V-311-3;
i) MPP Super Pig Starter C, product #341, packaged in 50
lb. bags. Recall # V-312-3;
j) MPP Super Pig Starter D, product #346, bulk and packaged
in 50-lb. bags. Recall # V-313-3;
k) Bulk custom mix swine ration containing denagard 10 and
CTC 50 meal. Recall # V-314-3;
l) Bulk custom mix swine ration containing Neo Terra 10-
5. Recall # V-315-3;
m) Bulk custom mix swine ration containing ASP.
Recall # V-316-3;
n) Bulk custom mix swine ration containing Tylan 40.
Recall # V-317-3;
o) Bulk custom swine mix ration containing Tylan 40.
Recall # V-318-3;
p) Bulk custom swine mix ration containing Tylan 40.
Recall # V-319-3;
q) Bulk custom mix swine ration containing Mecadox.
Recall # V-320-3.
CODE
a)/j) 022805 through 020111;
k) 5 deliveries invoiced 7/1/02, 7/5/02, and 9/9/02;
l) 2 deliveries invoiced 9/10/ & 12/02;
m) Invoiced 6/18/02;
n) Invoiced 7/2/02;
o) Invoiced 7/15/02 and 7/26/02;
p) Invoiced 8/7/02, 8/23/02 and 9/9/02;
q) Invoiced 9/16/02.
RECALLING FIRM/MANUFACTURER
English River Pellets, Inc., Kalona, IA, by letters dated April 29, 2003. FDA initiated recall is complete.
REASON
Firm received raw material ingredient zinc oxide from a supplier that contained elevated levels of dioxin.
VOLUME OF PRODUCT IN COMMERCE
196,430 lbs. bulk; 4,323/50-lb. bags.
DISTRIBUTION
IL, IA, and MN.
END OF ENFORCEMENT REPORT FOR OCTOBER 8, 2003
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Hypertext created by clb 2003-OCT-07.