FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

July 9, 2003
03-28

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

______________________________
PRODUCT
Frozen Marlin loins packed in shipping cartons labeled in part: Exporter Industria Marina Cristal Consigned to: Matica Inc Specie: Marlin Blanco Box # Net Weight Product of Costa Rica. Weights vary but are usually over 100 lbs. per case. Recall # F-405-3.
CODE
There are no codes on the product or the bulk cases. Shipment was received on or about April 15, 2003.
RECALLING FIRM/MANUFACTURER
Matica, Inc., Hialeah, FL, by telephone on May 11, 2003, and site visit on May 12, 2003. State initiated recall is complete.
REASON
The product was associated with illness and found to contain elevated levels of histamine.
VOLUME OF PRODUCT IN COMMERCE
2,406 pounds.
DISTRIBUTION
FL and IL.

______________________________
PRODUCT
a) Lynden Farms Frozen Hash Brown Potato patties.
10-2.25 oz. patties, 12 bags/case. Recall # F-414-3;
b) Simplot Frozen Hash Brown Potato patties. 20-2.25 oz.
patties. 12/20 pack cartons/case. Recall # F-415-3;
c) Simplot Frozen Classic 101 Hash Brown Potato patties.
Recall # F-416-3;
d) Nestle Carnation Frozen Shredded Hash Brown Potato
patties. This product is exclusively exported to Japan.
Recall # F-417-3.
CODE
a) 006 OCT 21 02, 006 OCT 23 02, 006 NOV 03 02;
b) 006 OCT 23 02, 006 OCT 24 02, 006 OCT 25 02,
006 NOV 05 02, 006 NOV 06 02, 006 NOV 07 02,
006 NOV 08 02, 006 NOV 11 02, 006 NOV 26 02;
c) 006 NOV 04 02, 006 NOV 05 02, 006 NOV 11 02,
006 NOV 12 02, 006 NOV 20 02;
d) 006 NOV 19 02.
RECALLING FIRM/MANUFACTURER
J. R. Simplot, Co. Corporate HQ, Boise, ID, via e-mail and fax on March 4, 2003 and March 6, 2003. Firm initiated recall is ongoing.
REASON
Frozen hash browns may contain plastic fragments.
VOLUME OF PRODUCT IN COMMERCE
a) 3,822 cases;
b) 12,734 cases;
c) 14,054 cases;
d) 947 cases.
DISTRIBUTION
Nationwide and Japan.

______________________________
PRODUCT
Jelfy Grape Flavored Gummy Added more fruit juice 20% net wt 80 grams product of Thailand , serving size 9 pieces (40 g) serving per container about 2. Recall # F-418-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Food King, Inc., West Haven, CT, by letter dated June 12, 2003. State initiated recall is ongoing.
REASON
Unapproved color additives - carmoisine and brilliant blue FCF.
VOLUME OF PRODUCT IN COMMERCE
61 cases.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

______________________________
PRODUCT
Metformin HCI, bulk drug powder, 50.0 Kg drums, for manufacturing, processing or repacking. Recall # D-273-3.
CODE
Lot #s: 202701MF1, 203601MF1, 203001MF1.
RECALLING FIRM/MANUFACTURER
ChemSource, Corp., Guayama, PR, by telephone on April 29, 2003, and May 19, 2003, followed by letters dated April 30, 2003, and May 20, 2003. Firm initiated recall is ongoing.
REASON
Cross-Contamination; product contains Etodolac.
VOLUME OF PRODUCT IN COMMERCE
3,689.5 kg.
DISTRIBUTION
WV and Canada.

______________________________
PRODUCT
Budesonide BP Micronized, 500mg, 5g, 1g, 25g, 100g bottles, Caution: For manufacturing, processing and repackaging. Recall # D-274-3.
CODE
Lot numbers: 03100205, 03100206, 03100207, 03100208, 03100209, and 03200307.
RECALLING FIRM/MANUFACTURER
Meridian Pharmaceuticals, Inc., Decatur, AL, by letters on June 4, 2003. Firm initiated recall is ongoing.
REASON
Subpotent.
VOLUME OF PRODUCT IN COMMERCE
276 grams.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
Levsin Elixir (hyoscyamine sulfate elixir USP), 0.125 mg/mL, 473 mL (1 pint) syrup, Rx only. Recall # D-270-3.
CODE
Lot 20920.
RECALLING FIRM/MANUFACTURER
Schwarz Pharma Manufacturing, Seymour, IN, by telephone on April 7, 2003, and by letters on May 14, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled; front label incorrectly states the product strength as 0.125 mg/mL rather than correctly as 0.125 mg/5 mL.
VOLUME OF PRODUCT IN COMMERCE
393 bottles.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
a) Coppertone_ Bug & Sun Sunscreen with Insect Repellent,
(N, N-diethyl-m-toluamide 9.5% and other isomers 0.5%),
SPF 30, Kid's Formula, 4 FL OZ (118mL) and 8 FL OZ
(237mL) bottles. Recall # D-271-3;
b) Coppertone_ Bug & Sun Sunscreen with Insect Repellent,
(N,N-diethyl-m-toluamide 9.5% and other isomers 0.5%),
SPF 30, Kid's Formula, 8 FL OZ (237mL) bottles. Recall # D-272-3.
CODE
a) 2D01PM, 2P02PM, and 3A01PM;
b) 1J01PM, 1M05PM, 1M01PM, 1M06PM, 1M05PM, 1M05APM,
1M04PM, 1N01PM, 1N06PM, 1N05PM, 1N04PM, 1N03PM,
1N02PM, 2A08PM, 2A04PM, 2A03PM, 2A02PM, 2A01PM,
2D03PM, 2E01PM, 2H01PM, 2J02PM, 2J01PM, 2K03PM,
2K02PM, 2K01PM, 2M01PM, 2N01PM, 2P01PM, 3A04PM,
3A02PM, 3B06PM, 3B01PM, 3B05PM, 3B04PM, 3B03PM,
M312005/3B06PM, M312005A, M312005B, M312105,
3C02PM, 3C01PM, and 3C03PM.
RECALLING FIRM/MANUFACTURER
Schering-Plough Health Care Products/DBA Bain deSoleil, Co., Cleveland, TN, by letters on May 30, 2003.
REASON
a) These lots contain trace quantities of an additional sunscreen,
benzophenone-4, which were incorrectly added to the formulation.
b) Certain lots of product may contain undeclared preservative.
VOLUME OF PRODUCT IN COMMERCE
902,519 units.
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
Lisinopril Tablets Usp, 10 mg, 10 tablet bottles, Sample Not To Be Sold. Recall # D-275-3.
CODE
Lot # 117955.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nucare Pharmaceuticals, Inc., Orange, CA, by letters on June 12, 2003.
Manufacturer: Ivax Pharmaceuticals, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Mislabeling; product label does not contain Rx only legend.
VOLUME OF PRODUCT IN COMMERCE
3,600 bottles.
DISTRIBUTION
CA.

______________________________
PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP), 1.25 mg, 100 and 1000 tablet bottles, Rx only. Recall # D-279-3.
CODE
Lots: #9000073B (100s) and #9000073W (1000s). Exp. Date on both lots is 07/04.
RECALLING FIRM/MANUFACTURER
National Pharmpak Services, Inc., Zanesville, OH, by letters dated February 24, 2003.
Manufacturer: Ayerst Laboratories, Inc., A Wyeth-Ayerst Company, Philadelphia, PA. Firm initiated recall is ongoing.
REASON
Dissolution failure by manufacturer (Wyeth)
VOLUME OF PRODUCT IN COMMERCE
34,378 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1205-3;
b) Cryoprecipitated AHF. Recall # B-1206-3.
CODE
a) and b) Unit number 3739820.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone, and by facsimile dated November 6, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, NJ, and NY.


RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

______________________________
PRODUCT
a) Platelets for Further Manufacture. Recall # B-1207-3;
b) Recovered Plasma. Recall # B-1208-3.
CODE
a) and b) Unit number 3739820.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone, and by facsimile dated November 6, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, NJ, and NY.

______________________________
PRODUCT
Platelets. Recall # B-1187-3.
CODE
Unit number 4321624.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone, and by facsimile dated August 12, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had received an MMR vaccination within three weeks of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

______________________________
PRODUCT
Source Plasma. Recall # B-1188-3.
CODE
Unit number AEO484.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Lynchburg, VA, by facsimile dated February 20, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested initially reactive for hepatitis B surface antigen (HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1265-3.
CODE
Unit number 20T28401.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID, by letter on May 6, 2002.
Manufacturer: The American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood product, that was found to be out of specification for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
UT.

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1266-3.
CODE
Unit number 16365-7522.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 12, 2002.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, possibly exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

______________________________
PRODUCT
ESPRIT Ventilator, Model V1000. Recall # Z-0951-03.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Respironics California, Inc., Carlsbad, CA, by Field Communication 2001-25 dated June 8, 2001. Firm initiated recall is complete.
REASON
Material hardness on original design check valve may cause premature failure.
VOLUME OF PRODUCT IN COMMERCE
749.
DISTRIBUTION
Nationwide, and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

______________________________
PRODUCT
Allen Medical Systems PAL Pro Stirrups. Catalog Number A-10051-A1. Recall # Z-0953-03.
CODE
Serial Numbers: A028661 through A028680.
RECALLING FIRM/MANUFACTURER
The OR Group, Inc., Acton, MA, by letter on June 6, 2003. Firm initiated recall is ongoing.
REASON
Foot Stirrups may detach from mount when user is locking system .
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
AL, CA, FL, GA, MO, and TN.

______________________________
PRODUCT
A) Vented and Non-Vented Burette I.V. Gravity Feed Administration
Sets; sterile, Rx, single use devices; Abbott Laboratories, North
Chicago, IL. Recall # Z-0955-03;
B) I.V. Extension Sets; sterile, Rx, single use devices; Abbott
Laboratories, North Chicago, IL. Please Note: items p, q & r
(list 191700204, 191700404 and 191700415) were packaged in kits
with Sporanox Injection distributed by Ortho Biotech Products,
Raritan, NJ. Recall # Z-0956-03;
C) Primary I.V. Gravity Administration Sets; sterile, Rx, single use
devices; Abbott Laboratories, North Chicago, IL. Please note,
item k, list 018810458, lot 910824W, was also case packed with
Liposyn II 20%, list 09793-04-03, lot 94533DF and
list 09792-04-02, lot 92522DF, distributed by Abbott Laboratories,
North Chicago, IL. Recall # Z-0957-03;
D) I.V. Pump Sets with Cassettes for use with Abbott Plum Series and
Lifecare Infusion Pumps; sterile, Rx, single use devices; Abbott
Laboratories, North Chicago, IL. Recall # Z-0958-03;
E) Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices.
Recall # Z-0959-03.
CODE
A) a) Latex-Free 250 mL Burette Set, Vented, 77 Inch Soluset,
list 017170402, lot 88006DT;
b) Latex-Free 100 mL Burette Set, Vented, 77 Inch Soluset,
list 017260402, lot 88100HG;
c) Latex-Free 150 mL Burette Set, Vented, 77 Inch,
list 018820468, lot 921495H;
d) Latex-Free 150 mL Burette Set, Vented, 100 Inch,
list 066460401, lot 911755H;
e) LifeShield Latex-Free 150 mL Burette Set, Vented, 100 Inch,
list 113980401, lots 88073HG, 90014HG;
f) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin,
77 Inch, list 119640402, lots 88070HG, 88139HG, 89064HG,
90008HG, 921105H, 951025H;
g) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin,
110 Inch, list 120720401, lot 90015HG;
h) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin,
77 Inch, list 123410401, lot 88081HG;
i) LifeShield Latex-Free Inline Burette Set 150 mL, Nonvented,
list 124250401, lots 85030HG, 88009HG, 88055HG, 910745H,
930175H;
j) 150 mL Burette Set, Nonvented, 77 Inch, list 153630468,
lot 931255H;
k) Latex-Free 150 mL Burette Set, Nonvented, 77 Inch,
list 153800468, lot 88068HG;
l) LifeShield Latex-Free 150 mL Burette Set, Vented, 108 Inch,
list 191890401, lot 89055HG
m) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin,
77 Inch, list 192080401, lots 87017HG, 87125HG, 891765H,
941045H, 961595H;
n) Venisystems Soluset 150 x 15, list 0E4031301, lot 86100HG;
o) LifeShield Latex-Free 150 mL Burette Set, Vented, Convertible
Pin, 77 Inch, list 117440401, lots 88106HG, 930145H, 961465H.
B) a) LifeShield Latex-Free Pediatric Extension Set, 10.5 Inch,
list 026940468, lots 910085H, 940405H;
b) LifeShield Latex-Free Pressure Activated Valve Extension Set
with Locking Spin Collar "T", list 047300402, lots 87080NS,
89099HG;
c) LifeShield Latex-Free VeniLoop Connector, list 114810401,
lot 891085H;
d) LifeShield Latex-Free Microbore Extension Set, 7 Inch,
list 119570402, lots 88057NS, 88103NS;
LifeShield Latex-Free Microbore Extension Set,
list 119580401, lots 87084NS, 88056NS, 88078NS, 89088NS,
89143NS, 89181NS;
LifeShield Latex-Free Microbore Extension Set with Clave,
Locking Spin Collar "T" and Prepierced Injection Site,
list 120530401, lots 86107NS, 87126NS, 88125NS;
LifeShield Latex-Free Macrobore Extension Set, 7 Inch,
list 120940402, lots 021045H, 88028HG, 88029HG, 88030HG,
88031HG, 891045H, 891875H, 891885H, 900165H, 900175H, 901015H,
910235H, 911485H, 920225H, 920785H, 921485H, 930425H, 930925H,
931205H, 940835H;
LifeShield Latex-Free Microbore Extension Set, 7 Inch, list 121130402, lot 87127NS;
LifeShield Latex-Free Macrobore Extension Set, list 123120401, lots 891095H, 910555H, 960775H;
LifeShield Latex-Free Microbore Extension Set, list 123130402, lots 86002HG, 86044HG, 87012HG, 87119HG, 90016HG, 90081NS, 92144NS;
LifeShield Latex-Free Microbore Extension Set INT, 6 Inch, list 123320401, lot 931375H;
LifeShield Latex-Free Tri-Leg Microbore Extension Set, list 123340401, lots 880605H, 891895H, 930945H, 950675H;
LifeShield Latex-Free Tri-Leg Extension Set, list 123460401, lots 88122HG, 89115HG, 920815H;
LifeShield Latex-Free Microbore Extension Set, list 124390401, lot 88176HG;
LifeShield Latex-Free Extension Set, 6 Inch, list 191420448, lots 87188HG, 89021HG, 93025R5;
Sterile Latex-Free Microbore Extension Set, list 191700204, lot 89135HG;
Sterile Latex-Free Microbore Extension Set, list 191700404, lots 010115H, 892045H, 911495H, 930965H, 940855H;
Microbore Extension Set, list 191700415, lot 961935H
LifeShield Latex-Free Macrobore Extension Set, 46 Inch, list 192220448, lots 921425H, 960425H;
LifeShield Latex-Free Y-Type Connecting Set, 9 Inch, list 193130448, lots 88138HG, 881405H, 941705H
LifeShield Latex-Free Macrobore Extension Set, list 193280448, lots 900545H, 910305H;
LifeShield Latex-Free Microbore Extension Set, 19 Inch, list 193320448, lot 02043R5; Please Note: items p, q & r (list 191700204, 191700404 and 191700415) were packaged in kits with Sporanox Injection distributed by Ortho Biotech Products, Raritan, NJ 08869.
a) Latex-Free Primary I.V. Set, Nonvented, 100 Inch, list
017280458, lots 920844W, 960784W;
b) Latex-Free Primary I.V. Set, Nonvented, 78 Inch, list 018180448,
lots 910604W, 960604W;
c) Latex-Free Primary I.V. Set, Nonvented, 100 Inch,
list 018190448, lot 020844W;
d) Latex-Free Primary I.V. Set, Convertible Pin, 70 Inch,
list 018200478, lots 880884W, 891554W, 910614W, 920824W,
931134W, 960614W;
e) Primary I.V. Set, Nonvented, 72 Inch, list 018570448,
lots 010524W, 900634W, 940624W;
f) Latex-Free Primary I.V. Set, Nonvented, 78 Inch, list 018590448,
lots 891184W, 900844W, 920784W, 930444W, 930884W, 931214W,
941274W, 950684W, 960504W;
g) Primary I.V. Set, Nonvented, 78 Inch, list 018600448,
lot 920654W;
h) Latex-Free Primary I.V. Set, Nonvented, 80 Inch,
list 018770468, lots 901224W, 941124W, 950484W;
i) Latex-Free Y-Type Primary I.V. Set, Nonvented, 86 Inch,
list 018790458, lot 960725H;
j) Latex-Free Primary I.V. Set, Vented, 78 Inch, list 018810448,
lots 860504W, 880454W, 890624W, 920904W;
k) Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch,
list 018810458, lots 890914W, 910824W, 911004W, 921134W,
930704W, 931234W, 931244W, 940544W, 950434W, 950694W, 951104W,
960524W, 960534W;
l) Latex-Free Primary I.V. Set, 78 Inch, list 030840448,
lot 960544W;
m) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch,
list 049670478, lots 020884W, 901274W, 921004W, 940834W;
n) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch,
list 049680478, lots 910894W, 921204W;
o) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch,
list 049850478, lots 020524W, 910844W, 931254W, 950624W;
p) Latex-Free Cardiac Catheterization Set, Nonvented, 67 Inch,
list 064140458, lot 931505H;
q) Latex-Free Manifold III with Secure Lock, list 064620401,
lot 89114HG;
r) Latex-Free Primary I.V. Set, Nonvented, 106 Inch,
list 080820448, lots 900874W, 901244W, 920974W, 930544W,
950634W, 950934W, 961044W;
s) Latex-Free Primary I.V. Set, Convertible Pin, 106 Inch,
list 080830478, lots 880834W; 931294W;
t) Primary I.V. Set, Vented, 72 Inch, list 089620448, lots 870514W,
880504W, 890934W, 891654W, 900524W, 901184W, 920554W;
u) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 113060458, lots 920984W, 931094W;
v) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
106 Inch, list 113080458, lots 920075H, 930455H, 940075H;
w) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
106 Inch, list 113090458, lots 871174W, 881054W, 901254W,
910854W, 920994W, 930554W, 930964W, 940584W, 940944W, 941304W,
950514W, 950524W, 950744W, 960584W;
x) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 114110478, lots 910654W, 950584W;
y) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
70 Inch, list 115390478, lots 880985H, 911035H, 931305H;
z) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
80 Inch, list 115400458, lots 870974W, 900934W, 911284W,
921184W, 940634W, 950664W, 960764W, 961104W, 961114W;
aa) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
78 Inch, list 115410458, lot 920115H;
bb) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
80 Inch, list 115420458, lot 921194W;
cc) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
78 Inch, list 115450458, lots 900964W, 910914W, 921224W,
931144W, 951124W; dd) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 80 Inch, list 115500478, lots 891354W, 951064W;
ee) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch,
list 115530458, lots 021235H, 911285H, 940325H;
ff) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 116780478, lot 87123HG;
gg) LifeShield Latex-Free Primary I.V. Set, Nonvented, 100 Inch,
list 116790448, lot 930075H;
hh) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
80 Inch, list 117190478, lot 881334W;
ii) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
80 Inch, list 117350478, lot 881395H;
jj) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
80 Inch, list 117360478, lot 900385H;
kk) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
70 Inch, list 117390478, lots 900355H, 940395H;
ll) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 117620478, lot 901435H
mm) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 119600468, lots 010544W, 020704W, 871204W,
900974W, 901104W, 901304W, 910664W, 910924W, 920684W,
920874W, 930594W, 930804W, 931154W, 940844W, 941004W,
941174W, 950594W, 950604W, 950824W, 960644W, 960874W;
nn) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 119610468, lots 010554W, 010564W, 010574W,
010584W, 010594W, 020714W, 870754W, 870764W, 870774W, 871034W,
880724W, 880744W, 880964W, 880994W, 890814W, 890824W, 901114W,
910674W, 910684W, 911334W, 920694W, 921014W, 921024W, 921264W,
921274W, 921284W, 921294W, 921304W, 930604W, 930614W, 930624W,
930634W, 930814W, 931004W, 931014W, 931164W, 940654W, 940664W,
940674W, 940854W, 940864W, 941014W, 941024W, 941034W, 941184W,
941194W, 941354W, 941364W, 950834W, 950844W, 950974W, 950984W,
951074W, 951084W, 951094W, 960884W, 961154W, 961164W, 961174W,
961184W;
oo) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 119620478, lots 891334W, 900584W, 901214W,
910574W, 911034W, 911254W, 920794W, 951114W;
pp) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 119630468, lots 020965H, 910035H, 910135H,
920015H, 930095H, 940085H, 960155H;
qq) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 119650468, lots 010404W, 010414W, 010424W,
020554W, 020564W, 020984W, 020994W, 021194W, 021204W, 870924W,
870934W, 870944W, 880474W, 911264W, 920474W, 920814W, 921074W,
930744W, 930754W, 930974W, 930984W, 931104W, 931414W, 931424W,
931434W, 940814W, 940824W, 940954W, 941154W, 941314W, 950534W,
950544W, 950754W, 960594W 960744W, 960754W, 960834W, 961054W,
961064W, 961074W;
rr) LifeShield Latex-Free Primary I.V. Set, Nonvented, 105 Inch,
list 119970448, lot 950155H;
ss) Latex-Free Primary I.V. Set, Convertible Pin, 112 Inch,
list 120580478, lot 911235H;
tt) LifeShield Latex-Free Primary I.V. Set, Nonvented, 110 Inch,
list 120590448, lots 020545H, 890185H;
uu) Latex-Free Fat Emulsion I.V. Set, Convertible Pin, 110 Inch,
list 120600458, lot 911515H;
vv) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 124260448, lot 921435H;
ww) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 124520448, lot 880685H;
xx) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 124530448, lots 020045H, 920295H;
yy) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
110 Inch, list 125720448, lot 88161HG;
zz) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
100 Inch, list 125740448, lot 921045H;
aaa) Primary I.V. Set, Nonvented, 72 Inch, list 150620448,
lot 911565H;
bbb) Latex-Free Primary I.V. Set, Convertible Pin, 84 Inch,
list 151280478, lot 89116HG;
ccc) Primary I.V. Set, Nonvented, 93 Inch, list 153550448,
lot 960315H;
ddd) Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch,
list 153990458, lot 892035H;
eee) Latex-Free Primary I.V. Set, Nonvented, 78 Inch, list 154090448,
lot 931085H;
fff) Latex-Free Primary I.V. Set, Convertible Pin, 83 Inch,
list 170400478, lot 940695H;
ggg) LifeShield Latex-Free Y-Type Anesthesia I.V. Set, Nonvented,
130 Inch, list 190580448, lot 87021HG;
hhh) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
135 Inch, list 190920401, lots 86025HG, 89013HG;
iii) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible
Piercing Pin, 112 Inch, list 191090448, lots 85047HG, 88078HG,
89108HG, 911625H;
jjj) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 112 Inch, list 191100448, lots 85048HG, 87014HG, 87151HG,
88059HG, 89053HG, 89122HG, 911635H, 931215H;
kkk) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 111 Inch, list 191110448, lots 85156HG, 87152HG, 89065HG,
910785H, 930485H;
lll) LifeShield Latex-Free Primary I.V. Set, Nonvented, 105 Inch,
list 191180448, lot 96019R5;
mmm) LifeShield Latex-Free Prim. I.V. Set, Convertible Pin, 110 Inch,
list 191330448, lots 03016R5, 93046R5, 94023R5, 95024R5;
nnn) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
124 Inch, list 191370458, lots 86039HG, 87154HG, 89039HG,
941165H, 961255H;
ooo) LifeShield Latex-Free Primary I.V. Set with Convertible Pin,
list 191520448, lot 88134HG;
ppp) LifeShield Latex-Free Primary Piggyback I.V. Set , Convertible
Pin, list 192070448, lot 01021R5;
qqq) LifeShield Latex-Free Primary I.V. Set, Convertible Piercing
Pin, 147 Inch, list 192170448, lots 011425H, 87036HG, 88110HG;
rrr) Latex-Free Primary I.V. Set, Convertible Pin, 82 Inch, list
192180448, lots 86142HG, 88095HG, 88170HG, 89111HG, 911085H,
941215H;
sss) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83
Inch, list 192290448, lots 87134HG, 88096HG, 930445H;
ttt) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
101 Inch, list 192410478, lots 88125HG, 88147HG, 891435H,
951525H;
uuu) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
107 Inch, list 192530448, lot 86139HG;
vvv) LifeShield Latex-Free Primary I.V. Set, Nonvented, 124 Inch,
list 192600401, lot 911005H;
zzz) LifeShield Latex-Free Primary I.V. Set, Nonvented, 110 Inch,
list 192620448, lot 960815H;
aaaa) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
141 Inch, list 192670448, lot 96020R5;
bbbb) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
126 Inch, list 192680448, lot 94019R5;
cccc) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible
Pin, 112 Inch, list 192770448, lots 020355H, 87020HG, 88111HG,
910815H, 930495H, 941055H, 950335H;
dddd) LifeShield Latex-Free Primary I.V. Set, Nonvented, 127 Inch,
list 192990448, lot 02057R5;
eeee) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
112 Inch, list 193110448, lots 87155HG, 960455H;
ffff) Latex-Free Primary I.V. Set, Convertible Pin, 83 Inch,
list 193210448, lots 871365H, 921025H;
gggg) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
111 Inch, list 193240448, lots 88079HG, 940255H
hhhh) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
104 Inch, list 193260448, lot 931355H;
iiii) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
138 Inch, list 193270448, lots 88014HG, 88051HG, 930505H,
941585H;
jjjj) LifeShield Latex-Free Primary I.V. Set, Nonvented, 102 Inch,
list 193310448, lot 01025R5;
kkkk) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
136 Inch, list 193440448, lots 02023R5, 88026R5, 89026R5,
92033R5;
llll) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
136 Inch, list 193490448, lot 95026R5;
mmmm) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
109 Inch, list 193570448, lots 02022R5, 86146HG, 93027R5;
nnnn) LifeShield Latex-Free Primary I.V. Set, Convertible Pin,
125 Inch, list 193590448, lot 88164HG; oooo) LifeShield
Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch,
list 195040448, lot 01032R5;
pppp) Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch with
2 Injection Sites, Microdrip, list 017230478, lots 891965H,
950585H;
qqqq) LifeShield Latex-Free Prim. I.V. Set, Convertible Pin, 110 Inch,
list 193480448,lots 87038HG, 901605H; Please note, item k,
list 018810458, lot 910824W, was also case packed with Liposyn
II 20%, list 09793-04-03, lot 94533DF and list 09792-04-02,
lot 92522DF.
D) a) LifeShield Latex-Free Primary I.V. Pump Set with Distal
Microbore Patient Line, Convertible Pin, 110 Inch, list
011690402, lots 90113NS, 92071NS, 94087NS, 94139NS, 96080NS;
b) Latex-Free Enteral PlumSet, Vented, 98 Inch, list 014790402,
lots 86119HG, 88086HG;
c) Latex-Free Enteral PlumSet, Vented, 98 Inch, list 014794202,
lot 87127HG;
d) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 016420448, lots 010365H, 011205H, 900955H,
910495H, 911415H, 920165H, 920665H, 930325H, 930865H, 931125H,
940725H, 940735H, 941405H, 941735H, 950165H, 950885H, 951205H,
961355H, 961625H;
e) LifeShield Latex-Free Secondary I.V. PlumSet, Convertible Pin,
32 Inch, list 016430448, lot 941635H;
f) LifeShield Latex-Free High-Pressure Filter Primary I.V. PlumSet,
Convertible Pin, 112 Inch, list 016440448, lot 911275H;
g) LifeShield Latex-Free High-Pressure Filter Primary I.V. PlumSet,
Convertible Pin, 112 Inch, list 016450448, lot 950085H;
h) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 016460448, lots 911105H, 941455H;
i) Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch,
list 016480448, lots 900965H, 901025H, 930875H;
j) Latex-Free Primary I.V. PlumSet -OL, Convertible Pin, list
016486148, lots 890695H, 890755H, 890765H, 910205H, 910505H,
911425H, 911435H, 921595H, 921605H, 930615H, 940435H;
k) Lifeshield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 016500448, lots 881515H, 900415H, 901615H,
911095H, 931135H, 941745H, 951215H, 961615H;
l) Latex-Free, Primary I.V. Plumset - OL, Convertible Pin,
104 Inch, list 016516148, lots 891265H, 891275H, 891285H,
901575H, 901585H, 930345H, 930725H, 930735H, 941225H;
m) LifeShield Latex-Free Microdrip Primary I.V. PlumSet,
Convertible Pin, 104 Inch, list 017350478, lot 911045H;
n) Latex-Free Soluset 150 mL Burette I.V. Pump Set, Vented,
114 Inch, list 017530402, lots 87121HG, 87173HG, 88064HG,
88101HG, 89048HG, 911555H;
o) Latex-Free Nitroglycerin Primary I.V. Pump Set, Convertible Pin,
107 Inch, list 017720478, lot 900265H;
p) LifeShield Latex-Free Microdrip Nitroglycerin PlumSet,
Convertible Pin, 107 Inch, list 024270478, lot 930625H;
q) LifeShield Latex-Free Microdrip Nitroglycerine PlumSet,
Convertible Pin, list 024276178, lot 950185H;
r) Latex-Free Primary I.V. Pump Set, Convertible Pin, 105 Inch,
list 037040478, lots 021255H, 890395H, 900475H, 901375H,
901385H, 910265H, 920245H, 940305H;
s) Latex-Free Primary I.V. PlumSet, Convertible Pin, 107 Inch,
list 064400412, lots 890165H, 920465H, 941415H
t) LifeShield Latex-Free Microdrip Soluset 50 mL Burette PlumSet,
Convertible Pin, 105 Inch, list 064460403, lot 87136HG;
u) Latex-Free Enteral PlumSet with Integral Container, Nonvented,
105 Inch, list 064920402, lots 031024W, 88046HG;
v) Latex-Free Microdrip Primary I.V. Micro Pump Set, Vented,
102 Inch, list 092430448, lots 891975H, 920065H;
w) Latex-Free Soluset Microdrip 150 mL Burette Micro Pump Set,
Vented, 124 Inch, list 092470468, lots 88063HG, 88152HG,
89061HG;
x) Latex-Free Specialty I.V. Pump Set-HB, Convertible Pin,
105 Inch, list 111550478, lot 88149HG;
y) LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch,
list 112350403, lots 87037HG, 88104HG, 89101HG, 920855H,
940175H;
z) LifeShield Latex-Free Hemoset 100 mL Burette I.V. PlumSet,
Nonvented, 105 Inch, list 112410403, lots 85031HG, 87169HG,
90013HG, 921515H;
aa) Latex-Free Primary I.V. PlumSet, Nonvented, 112 Inch, list
113400402, lots 86082HG, 910625H, 930825H, 950555H, 961085H;
bb) LifeShield Latex-Free Secondary I.V. PlumSet, Convertible Pin,
18 Inch, list 114170478, lots 900665H, 930555H;
cc) LifeShield Latex-Free Primary I.V. PlumSet, Nonvented, 104 Inch,
list 114190412, lots 011215H, 951095H;
dd) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 115940412, lots 87074HG, 920405H;
ee) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 115950412, lots 85164HG, 941665H;
ff) Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch,
list 116060401, lots 850515H, 881345H;
gg) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 116620412, lots 930785H, 950565H;
hh) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented,
122 Inch, list 116640403, lots 85052HG, 910705H, 920555H,
941005H, 950305H, 951015H;
ii) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 116870401, lot 010915H;
jj) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin,
105 Inch, list 116970448, lots 891235H, 940595H;
kk) Latex-Free Soluset 150 mL Burette PlumSet, Convertible Pin,
114 Inch, list 117060402, lots 87144HG, 88105HG, 89049HG,
930135H;
ll) LifeShield Latex-Free Microdrip Soluset 150 mL Burette PlumSet,
Convertible Pin, 124 Inch, list 117140402, lot 89097HG;
mm) LifeShield Latex-Free HEMOSET, 100 mL Burette I.V. PlumSet,
Nonvented, 141 Inch, list 118500402, lot 942025H;
nn) Latex-Free Secondary I.V. PlumSet, Convertible Pin, 18 Inch,
list 118770448, lots 900295H, 920485H, 940415H, 960145H;
oo) Latex-Free Nitroglycerin PlumSet, Convertible Pin, 107 Inch,
list 118780412, lots 901445H, 910635H, 920415H, 930565H,
941685H, 951135H;
pp) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 118840458, lots 01016R5, 88088HG, 92047R5,
93053R5;
qq) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 119430412, lots 010385H, 010985H, 020155H,
020165H, 020175H, 020605H, 891475H, 891595H, 891605H, 891625H,
891635H, 900425H, 900435H, 900445H, 900455H, 900985H, 920175H,
920185H, 930245H, 930365H, 930375H, 930385H, 930635H, 930645H,
930655H, 930665H, 930885H, 931145H, 931155H, 931165H, 940445H,
940455H, 940465H, 940475H, 940485H, 940745H, 940755H, 940765H,
940775H, 941265H, 941275H, 941285H, 941465H, 941475H, 941755H,
941765H, 941775H, 950245H, 950255H, 950265H, 950625H, 951235H;
rr) LifeShield Latex-Free Microdrip Soluset with High-Pressure
Filter 150 mL Burette PlumSet, Convertible Pin, 139 Inch,
list 119440402, lots 84133HG, 84156HG, 88076HG;
ss) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
112 Inch, list 119460412, lots 84180HG, 930285H, 940335H,
940605H;
tt) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 119470412, lot 941185H;
uu) LifeShield Latex-Free Microdrip Soluset 150 mL Burette PlumSet,
Convertible Pin, 124 Inch, list 119480402, lots 84022HG,
85023HG, 87034HG, 87146HG, 87182HG, 87183HG, 88065HG, 88107HG,
940195H, 940895H, 950315H, 951345H;
vv) LifeShield Latex-Free Microdrip Soluset with High-Pressure
Filter 150 mL Burette PlumSet, Convertible Pin, 139 Inch,
list 119490402, lot 88108HG;
ww) Latex-Free Microdrip Soluset 150 mL Burette Pump Set,
Convertible Piercing Pin, 124 Inch, list 119760402, lots
88109HG, 89063HG, 90002HG, 911775H;
xx) LifeShield Latex-Free Microdrip Soluset 150 mL Burette PlumSet,
Convertible Pin, 124 Inch, list 119770403, lots 88131HG,
89124HG, 920865H, 961055H;
yy) LifeShield Latex-Free Soluset 150 mL Burette I.V. PlumSet,
Convertible Pin, 114 Inch, list 119790402, lot 87147HG;
zz) LifeShield Latex-Free Microdrip Soluset with High-Pressure
Filter 150 mL Burette PlumSet, Convertible Pin, 139 Inch,
list 119800403, lots 89051HG, 960905H;
aaa) Latex-Free Nitroglycerin Primary I.V. Pump Set, Convertible Pin,
110 Inch, list 119930478, lots 910145H, 920125H;
bbb) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 120300412, lots 021365H, 860795H, 860815H,
860955H, 871125H, 881455H, 881505H, 881525H, 890795H, 891295H,
891645H, 892075H, 901005H, 901335H, 901345H, 901355H, 911125H,
920205H, 920215H, 930895H, 940505H, 940515H, 941485H, 941785H;
ccc) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 121190412, lot 960645H;
ddd) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin,
110 Inch, list 121610401, lots 86121HG, 87105NS, 89111NS,
89158NS, 90072NS;
eee) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin,
110 Inch, list 121620401, lots 01061NS, 89112NS;
fff) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin,
110 Inch, list 121630401, lots 88173HG, 89139NS;
ggg) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented,
122 Inch, list 122590402, lots 010775H, 030885H, 85045HG,
87031HG, 87148HG, 88057HG, 880805H, 890465H, 891745H, 901505H,
930165H, 940205H, 951355H, 960385H;
hhh) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 122600412, lots 010055H, 900375H, 900395H,
920155H, 921765H, 930055H, 940065H, 940425H, 961125H;
iii) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 123390412, lot 931075H;
jjj) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin,
110 Inch, list 123830401, lots 87004HG, 87174HG, 88132HG,
891325H, 911325H, 960395H;
kkk) LifeShield Latex-Free Fat Emulsion I.V. PlumSet, Convertible
Pin, 104 Inch, list 125380448, lot 951435H;
lll) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
112 Inch, list 125630412, lot 951455H;
mmm) LifeShield Latex-Free 150 mL Burette PlumSet, Convertible Pin,
114 Inch, list 125640402, lot 951485H;
nnn) LifeShield Latex-Free GemStar Primary Piggyback Pump Set-SL,
Convertible Pin, 110 Inch, list 132670401, lot 942315H;
ooo) Latex-Free GemStar Primary Piggyback I.V. Pump Set-SL, list
132686101, lots 86106HG, 88042HG;
ppp) Latex-Free Enteral PlumSet, Nonvented, 98 Inch, list 190140402,
lots 87132HG, 942095H, 93049R5, 93050R5, 95022R5;
qqq) Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch,
list 190430412, lot 88089HG;
rrr) LifeShield Latex-Free Primary I.V. PlumSet, Nonvented, 113 Inch,
list 190500412, lots 911255H, 950045H;
sss) LifeShield Latex-Free Nitroglycerin Primary I.V. PlumSet,
Convertible Pin, 107 Inch, list 190860412, lot 93033R5;
ttt) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented,
118 Inch, list 191210402, lots 87153HG, 88056HG;
uuu) LifeShield Latex-Free Primary I.V. Plumset, Convertible Pin,
104 Inch, list 192100412, lots 89110HG, 93044R5, 96039R5;
vvv) LifeShield Latex-Free Microdrip Soluset with High-Pressure
Filter 150 mL Burette PlumSet, Convertible Pin, 124 Inch, list
192310412, lot 85181HG
www) LifeShield Latex-Free 50 mL Burette PlumSet, Convertible Pin,
107 Inch, list 192540402, lot 89128HG;
aaaa) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
135 Inch, list 192650448, lots 86036R5, 89029R5, 92044R5,
96018R5;
bbbb) LifeShield Latex-Free Microdrip Soluset 100 mL Burette PlumSet,
Convertible Pin, 121 1/2 Inch, list 192890402, lots 85034H G,
85059HG, 88083HG, 960445H;
cccc) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
103 Inch, list 193060412, lots 01019R5, 92042R5, 92043R5,
941395H;
dddd) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
110 Inch, list 193380412, lots 01026R5, 87170HG, 92046R5;
eeee) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
108 Inch, list 193400412, lots 02058R5, 94040R5;
ffff) LifeShield Latex-Free Microdrip Soluset with High-Pressure
Filter 150 mL Burette PlumSet, Convertible Pin, 137 Inch,
list 193470402, lot 960945H;
gggg) LifeShield Latex-Free Soluset 100 mL Burette PlumSet,
Convertible Pin, 121 Inch, list 193510402, lots 84043HG,
911825H, 950355H;
hhhh) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin,
104 Inch, list 193600412, lots 88163HG, 88169HG, 921785H;
E) a) Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch,
list 018320468, lots 010015H, 911055H, 921285H, 940565H,
950785H;
b) Latex-Free Secondary I.V. Set, Nonvented, 32 Inch, list
018610458, lots 901305H, 910215H, 921465H, 960735H;
c) Latex-Free Secondary I.V. Set, Convertible Pin, 35 Inch,
list 018890458, lots 920695H, 950175H;
d) Latex-Free Secondary I.V. Set with Convertible Pin, 32 Inch,
list 019110448, lots 85163HG, 960535H;
e) Latex-Free Secondary I.V. Set, Nonvented, 35 Inch, list
019260448, lot 941645H;
f) Latex-Free Midlength Secondary I.V. Set, 40 Inch, list
111810401, lots 86029HG, 89100HG;
g) LifeShield Latex-Free Secondary I.V. Set, Nonvented, 32 Inch,
list 113110448, lots 010324W, 010724W, 910534W, 920934W,
930494W, 950444W, 950714W;
h) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin,
32 Inch, list 113970458, lots 910624W, 910634W, 911304W,
920674W, 920854W, 920864W, 921214W, 930784W, 931314W, 931324W,
940994W, 941334W, 950574W, 950814W, 950964W, 951054W, 960794W,
960864W;
i) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin,
32 Inch, list 114850458, lot 911234W;
j) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin,
32 Inch, list 119530448, lots 010464W, 010474W, 010484W,
010494W, 010504W, 010794W, 010804W, 020634W, 020654W, 020664W,
021034W, 870534W, 870554W, 870874W, 870884W, 871114W, 880674W,
890674W, 900864W, 901044W, 910554W, 910834W, 911244W, 920564W,
920574W, 920944W, 920954W, 921174W, 930504W, 930514W, 930524W,
930714W, 930724W, 930924W, 930934W, 931064W, 931074W, 940554W,
940564W, 940774W, 940784W, 940914W, 940924W, 941104W, 941114W,
941284W, 941294W, 9500464W, 950474W, 950724W, 950924W, 960564W,
960984W, 960994W, 961004W;
k) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin, 32
Inch, list 119540448, lots 860994W, 861244W;
l) ColorGard Latex-Free Midlength Secondary I.V. Set, Convertible
Pin, 40 Inch, list 405210448, lot 911265H;
m) ColorGard Latex-Free Midlength Secondary I.V. Set, Convertible
Pin, 40 Inch, list 405220448, lots 890215H, 950135H;
n) ColorGard Latex-Free Midlength Secondary I.V. Set, Convertible
Pin, 40 Inch, list 405240448, lots 910075H, 910155H;
o) Latex-Free Midlength Secondary I.V. Set, Convertible Pin,
40 Inch, list 011390448, lots 010814W, 880514W, 900944W,
901094W, 901264W, 910884W, 920834W, 921084W, 930574W, 930764W,
940644W, 940974W, 950564W, 950804W, 960634W, 960854W, 961134W;
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letters dated June 9, 2003, and June 13, 2003. Firm initiated recall is ongoing.
REASON
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
VOLUME OF PRODUCT IN COMMERCE
68,946,133 sets.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

______________________________
PRODUCT
Exradin A12 Ionization Chamber. Recall # Z-0952-03.
CODE

Serial numbers XA030414, XA030413, XA030412, XA030411, XA030281, XA030225, XA030224, XA023341, XA023251, XA022101, XA021649, XA021645, XA021642, XA021641, XA020741, XA020176, XA020171, XA020143, XA013118, XA012743, XA012741, XA011444, XA392, 390, and 345.
RECALLING FIRM/MANUFACTURER
Standard Imaging, Inc., Middleton, WI, by telephone, and letter dated May 28, 2003. Firm initiated recall is ongoing.
REASON
Ionization chambers, used for checking x-ray equipment, are experiencing some drift from the tested calibration factors.
VOLUME OF PRODUCT IN COMMERCE
25 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

______________________________
PRODUCT
Pig Starter Crumbles Type B Medicated Feed. Net Wt. 50 lbs.
Recall # V-177-3.
CODE
Lot number 3709.
RECALLING FIRM/MANUFACTURER
Poulin Grain, Inc., Newport, VT, by letter on March 20, 2003, and March 24, 2003. Firm initiated recall is ongoing.
REASON
Medicated feed was manufactured with expired antibiotic.
VOLUME OF PRODUCT IN COMMERCE
91/50 lb. bags.
DISTRIBUTION
ME, NH, NY, RI, and VT.

END OF ENFORCEMENT REPORT FOR JULY 9, 2003

###


FDA News Page   |   FDA Home Page


Office of Public Affairs
Hypertext created by clb 2003-JUL-09.