JULY 2003

 

WEEK ENDING JULY 5

 

PRODUCT OmniDiagnost x-ray systems.
CODE All OmniDiagnost x-ray systems.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell, WA.
REASON The units do not provide the source to image receptor distance (SID) on the beam limiting device.
VOLUME OF PRODUCT IN COMMERCE Approximately 42 units.
DISTRIBUTION Nationwide.

 

PRODUCT Rational Imaging TM Software, model Ultra 10 PACS System.
CODE RIUpdate 7.1.OK.
RECALLING FIRM/MANUFACTURER Canon USA, Inc., Irvine, CA.
REASON Imaging archive system software mismatches images and patient names.
VOLUME OF PRODUCT IN COMMERCE 34.
DISTRIBUTION IA, CA, AR, WA, and OR.


PRODUCT ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR 40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusion Set.
CODE ATF 40 Fast Start Kit - Catalog no. 9108491, batch no. NKT257 AT1: Catalog no. 9005101, lot no. NHT272.
RECALLING FIRM/MANUFACTURER Fresenius Hemocare, Inc., Redmond, WA.
REASON Sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE 1,264.
DISTRIBUTION Nationwide.


PRODUCT TransFx Pin, External Fixation Pin. 3.0/4.0mm x 80mm, 20mm thread.
CODE Catalog No./Part No./Ref. No. 00-4453-34-08. Lot Number: 70209800.
RECALLING FIRM/MANUFACTURER Immedica, Inc., Chatham, NJ.
REASON Mislabeled, wrong identification number on pin.
VOLUME OF PRODUCT IN COMMERCE 127.
DISTRIBUTION OH.


PRODUCT Model 8666 Washer/Disinfector with holding tank heater option.
CODE Serial numbers 81972 through 82063; and SEV0141098 through SEV0304112.
RECALLING FIRM/MANUFACTURER Getinge/Castle, Inc., Rochester, NY.
REASON Hot water may splash from the washer chamber creating a burn hazard.
VOLUME OF PRODUCT IN COMMERCE 75 units.
DISTRIBUTION Nationwide.


PRODUCT Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6516C, 6516F, and 6518C. (The different product codes are for the various countries where the product is distributed).
CODE Serial numbers 168252 through 169574.
RECALLING FIRM/MANUFACTURER Bayer HealthCare LLC, Diagnostics Div., Elkhart, IN.
REASON Analyzer will produce erroneous results due to missing grounding strap.
VOLUME OF PRODUCT IN COMMERCE 1,324.
DISTRIBUTION Nationwide, and Internationally.


PRODUCT Supergrade Earloop Masks, surgical mask; 50 masks per box.
CODE All lots of product code 372-8114 (blue) and 372-8125 (pink).
RECALLING FIRM/MANUFACTURER Safco Dental Supply Co., Inc., Northbrook, IL.
REASON The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
VOLUME OF PRODUCT IN COMMERCE 60,000 boxes.
DISTRIBUTION Nationwide.


PRODUCT a) Uroview 2000 X-ray System. b) Uroview 2500 X-ray System. c) Uroview 2600 Uroview System.
CODE
a) Serial numbers beginning with T2 and T9;
b) Serial numbers beginning with M2 and M9;
c) Serial numbers beginning with W2 and W9.
RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT.
REASON Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
VOLUME OF PRODUCT IN COMMERCE 1,109 units.
DISTRIBUTION Nationwide, and Internationally.


PRODUCT StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer.
CODE Lot 77091367.
RECALLING FIRM/MANUFACTURER Pioneer Surgical Technology, Marquette, MI.
REASON Label may bear an incorrect part number (2227-02-02) and size (03.8MM).
VOLUME OF PRODUCT IN COMMERCE 159.
DISTRIBUTION IN.

 

PRODUCT Alpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws.
CODE Lot 251219G.
RECALLING FIRM/MANUFACTURER Alphatec Mfg., Inc., Carlsbad, CA.
REASON Laser marking is wrong on bone screws, says 40 and is 45 mm long.
VOLUME OF PRODUCT IN COMMERCE 31.
DISTRIBUTION FL, MD, CA, TX, Greece and Japan.


PRODUCT Fixion PF ("Proximal Femur") Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110mm, 111mm, 120mm, and 121mm. The Fixion PF Hip Peg is intended for use in the fixation of proximal fractures in the femur.
CODE
Catalog # Lot # 4418080 -- PF02385; PF02437; PF02477; PF02696; PF02697; PF02695; PF02378; PF02333; 4408080 -- FP-1161; FP-1094; FP01176; FP-1089; 4408081 -- PF02333; 4418090 -- PF02701; PF02700; PF02478; PF02438; PF02640; 4408101 -- PF02335; 4418105 -- PF02336;

4408111 -- PF02193; 4418110 -- PF02713; PF02712; PF02709; PF02641; PF02495;  PF02480; PF02440; PF02387; PF02380; 4408110 -- FP01175;

FP-1147; FP-1097; FP-1092; 4408090 -- FP01179; FP-1163; FP-1095; FP-1090; 271201; 4408091 -- PF02192; 4418095 -- PF02334; 4408100 -- FP-1096; FP-1091; FP01178; FP-1160; 4418100 -- PF02335; PF02707; PF02371; PF02379; PF02386;  PF02439; PF02479; PF02703; PF02705; PF02706;

4418120 -- PF02715; PF02714; PF02539; PF02441; PF02388; PF02381; PF02372; PF02337; 4408120 -- FP01177; FP-1162; FP-1098; FP-1093;

4408121 -- PF02337.

RECALLING FIRM/MANUFACTURER Disc Orthopaedic Technologies, Inc., Cranbury, NJ.
REASON The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.
VOLUME OF PRODUCT IN COMMERCE 1,540.
DISTRIBUTION
Nationwide.


PRODUCT Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029.
CODE Lot 074461.
RECALLING FIRM/MANUFACTURER The Binding Site, Inc, San Diego, CA.
REASON Risk of false positives.
VOLUME OF PRODUCT IN COMMERCE 239.
DISTRIBUTION Nationwide.

 

WEEK ENDING JULY 12

 

PRODUCT ESPRIT Ventilator, Model V1000.

CODE All Codes.
RECALLING FIRM/MANUFACTURER Respironics California, Inc., Carlsbad, CA.
REASON Material hardness on original design check valve may cause premature failure.
VOLUME OF PRODUCT IN COMMERCE 749.
DISTRIBUTION Nationwide, and Internationally.


PRODUCT Allen Medical Systems PAL Pro Stirrups. Catalog Number A-10051-A1.

CODE Serial Numbers: A028661 through A028680.
RECALLING FIRM/MANUFACTURER The OR Group, Inc., Acton, MA.
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.

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.
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.
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.
E) Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices.
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.

C) 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.
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.


PRODUCT Exradin A12 Ionization Chamber.
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.
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.

 

WEEK ENDING JULY 19


PRODUCT Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
CODE Serial numbers 81972 through 82063, and SEV0141098 through SEV0304112.
RECALLING FIRM/MANUFACTURER Getinge/Castle, Inc., Rochester, NY.
REASON Hot water may splash from the washer chamber creating a burn hazard.
VOLUME OF PRODUCT IN COMMERCE 75 units.
DISTRIBUTION Nationwide.


PRODUCT Evita 4 Continuous Ventilator. Catalog numbers 4116640 and 8412980.
CODE Software version 4.00 or 4.10.
RECALLING FIRM/MANUFACTURER Draeger Medical, Inc., Telford, PA.
REASON Software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
VOLUME OF PRODUCT IN COMMERCE 806 units.
DISTRIBUTION Nationwide, and Canada.

 

WEEK ENDING JULY 26


PRODUCT

A)Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single use devices; 15 different sets listed.

a) Latex-Free 250 mL Burette Set, Vented, 77 Inch Soluset;
b) Latex-Free 100 mL Burette Set, Vented, 77 Inch Soluset;
c) Latex-Free 150 mL Burette Set, Vented, 77 Inch;
d) Latex-Free 150 mL Burette Set, Vented, 100 Inch;
e) LifeShield Latex-Free 150 mL Burette Set, Vented, 100 Inch;
f) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin, 77 Inch;
g) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin, 110 Inch;
h) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin, 77 Inch;
i) LifeShield Latex-Free Inline Burette Set 150 mL, Nonvented;
j) 150 mL Burette Set, Nonvented, 77 Inch;
k) Latex-Free 150 mL Burette Set, Nonvented, 77 Inch;
l) LifeShield Latex-Free 150 mL Burette Set, Vented, 108 Inch;
m) LifeShield Latex-Free 150 mL Burette Set, Convertible Pin, 77 Inch;
n) Venisystems Soluset 150 x 15;
o) LifeShield Latex-Free 150 mL Burette Set, Vented, Convertible Pin, 77 Inch;
B) I.V. Extension Sets; sterile, Rx, single use devices; 22 different sets listed in the code information section below.
a) LifeShield Latex-Free Pediatric Extension Set, 10.5 Inch;
b) LifeShield Latex-Free Pressure Activated Valve Extension Set with Locking Spin Collar "T";
c) LifeShield Latex-Free VeniLoop Connector;
d) LifeShield Latex-Free Microbore Extension Set, 7 Inch;
e) LifeShield Latex-Free Microbore Extension Set;
f) LifeShield Latex-Free Microbore Extension Set with Clave, Locking Spin Collar "T" and Prepierced Injection Site;
g) LifeShield Latex-Free Macrobore Extension Set, 7 Inch;
h) LifeShield Latex-Free Microbore Extension Set, 7 Inch;
i) LifeShield Latex-Free Macrobore Extension Set;
j) LifeShield Latex-Free Microbore Extension Set;
k) LifeShield Latex-Free Microbore Extension Set INT, 6 Inch;
l) LifeShield Latex-Free Tri-Leg Microbore Extension Set;
m) LifeShield Latex-Free Tri-Leg Extension Set;
n) LifeShield Latex-Free Microbore Extension Set;
o) LifeShield Latex-Free Extension Set, 6 Inch;
p) Sterile Latex-Free Microbore Extension Set;
q) Sterile Latex-Free Microbore Extension Set;
r) Microbore Extension Set;
s) LifeShield Latex-Free Macrobore Extension Set, 46 Inch;
t) LifeShield Latex-Free Y-Type Connecting Set, 9 Inch;
u) LifeShield Latex-Free Macrobore Extension Set;
v) LifeShield Latex-Free Microbore Extension Set, 19 Inch;
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.
C) Primary I.V. Gravity Administration Sets; sterile, Rx, L 60064 USA; 95 different sets listed.
a) Latex-Free Primary I.V. Set, Nonvented, 100 Inch;
b) Latex-Free Primary I.V. Set, Nonvented, 78 Inch;
c) Latex-Free Primary I.V. Set, Nonvented, 100 Inch;
d) Latex-Free Primary I.V. Set, Convertible Pin, 70 Inch;
e) Primary I.V. Set, Nonvented, 72 Inch;
f) Latex-Free Primary I.V. Set, Nonvented, 78 Inch;
g) Primary I.V. Set, Nonvented, 78 Inch;
h) Latex-Free Primary I.V. Set, Nonvented, 80 Inch;
i) Latex-Free Y-Type Primary I.V. Set, Nonvented, 86 Inch;
j) Latex-Free Primary I.V. Set, Vented, 78 Inch;
k) Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch;
l) Latex-Free Primary I.V. Set, 78 Inch;
m)Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
n) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
o) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
p)Latex-Free Cardiac Catheterization Set, Nonvented, 67 Inch;
q) Latex-Free Manifold III with Secure Lock;
r) Latex-Free Primary I.V. Set, Nonvented, 106 Inch,
s) Latex-Free Primary I.V. Set, Convertible Pin, 106 Inch;
t) Primary I.V. Set, Vented, 72 Inch;
u) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
v) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 106 Inch;
w) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 106 Inch;
x) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
y) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 70 Inch;
z) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
aa) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch;
bb) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
cc) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch;
dd) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
ee) Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
ff) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
gg) LifeShield Latex-Free Primary I.V. Set, Nonvented, 100 Inch;
hh) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
ii) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
jj) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch;
kk) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 70 Inch;
ll) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
mm) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
nn) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
oo) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
pp) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
qq) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
rr) LifeShield Latex-Free Primary I.V. Set, Nonvented, 105 Inch;
ss) Latex-Free Primary I.V. Set, Convertible Pin, 112 Inch;
tt) LifeShield Latex-Free Primary I.V. Set, Nonvented, 110 Inch;
uu) Latex-Free Fat Emulsion I.V. Set, Convertible Pin, 110 Inch;
vv) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
ww) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
xx) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
yy) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 110 Inch;
zz) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch;
aaa) Primary I.V. Set, Nonvented, 72 Inch;
bbb) Latex-Free Primary I.V. Set, Convertible Pin, 84 Inch;
ccc) Primary I.V. Set, Nonvented, 93 Inch;
ddd) Latex-Free Primary I.V. Set, Convertible Pin, 78 Inch;
eee) Latex-Free Primary I.V. Set, Nonvented, 78 Inch;
fff) Latex-Free Primary I.V. Set, Convertible Pin, 83 Inch;
ggg) LifeShield Latex-Free Y-Type Anesthesia I.V. Set, Nonvented, 130 Inch;
hhh) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 135 Inch;
iii) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible Piercing Pin, 112 Inch;
jjj) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 112 Inch;
kkk) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 111 Inch;
lll) LifeShield Latex-Free Primary I.V. Set, Nonvented, 105 Inch;
mmm) LifeShield Latex-Free Prim. I.V. Set, Convertible Pin, 110 Inch;
nnn) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 124 Inch;
ooo) LifeShield Latex-Free Primary I.V. Set with Convertible Pin;
ppp) LifeShield Latex-Free Primary Piggyback I.V. Set, Convertible Pin;
qqq) LifeShield Latex-Free Primary I.V. Set, Convertible Piercing Pin, 147 Inch;
rrr) Latex-Free Primary I.V. Set, Convertible Pin, 82 Inch;
sss) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 Inch;
ttt) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 101 Inch;
uuu) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 107 Inch;
vvv) LifeShield Latex-Free Primary I.V. Set, Nonvented, 124 Inch;
zzz) LifeShield Latex-Free Primary I.V. Set, Nonvented, 110 Inch;

aaaa) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 141 Inch;

 bbbb) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 126 Inch;
 cccc) Continuum LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 112 Inch;
dddd) LifeShield Latex-Free Primary I.V. Set, Nonvented, 127 Inch;
eeee) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 112 Inch;
ffff) Latex-Free Primary I.V. Set, Convertible Pin, 83 Inch;
gggg) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 111 Inch;
hhhh) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 104 Inch;
iiii) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 138 Inch;
jjjj) LifeShield Latex-Free Primary I.V. Set, Nonvented, 102 Inch;
kkkk) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 136 Inch;
llll) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 136 Inch;
mmmm) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 109 Inch;
nnnn) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 125 Inch;
oooo) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 80 Inch,;
pppp) Latex-Free Primary I.V. Set, Convertible Pin, 100 Inch with 2 Injection Sites, Microdrip;
qqqq) LifeShield Latex-Free Prim. I.V. Set, Convertible Pin, 110 Inch.
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) I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single
use devices; 86 different sets listed.
a) LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line, Convertible Pin, 110 Inch;
b) Latex-Free Enteral PlumSet, Vented, 98 Inch;
c) Latex-Free Enteral PlumSet, Vented, 98 Inch;
d) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
e) LifeShield Latex-Free Secondary I.V. PlumSet, Convertible Pin, 32 Inch;
f) LifeShield Latex-Free High-Pressure Filter Primary I.V. PlumSet, Convertible Pin, 112 Inch;
g) LifeShield Latex-Free High-Pressure Filter Primary I.V. PlumSet, Convertible Pin, 112 Inch
h) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;

   i)Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
j) Latex-Free Primary I.V. PlumSet -OL, Convertible Pin;
k) Lifeshield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
l) Latex-Free, Primary I.V. Plumset - OL, Convertible Pin, 104 Inch;
m) LifeShield Latex-Free Microdrip Primary I.V. PlumSet, Convertible Pin, 104 Inch;
n) Latex-Free Soluset 150 mL Burette I.V. Pump Set, Vented, 114 Inch;
o) Latex-Free Nitroglycerin Primary I.V. Pump Set, Convertible Pin, 107 Inch;
p) LifeShield Latex-Free Microdrip Nitroglycerin PlumSet, Convertible Pin, 107 Inch;
q) LifeShield Latex-Free Microdrip Nitroglycerine PlumSet, Convertible Pin;
r) Latex-Free Primary I.V. Pump Set, Convertible Pin, 105 Inch;
s) Latex-Free Primary I.V. PlumSet, Convertible Pin, 107 Inch;
t) LifeShield Latex-Free Microdrip Soluset 50 mL Burette PlumSet, Convertible Pin, 105 Inch;
u) Latex-Free Enteral PlumSet with Integral Container, Nonvented, 105 Inch;
v) Latex-Free Microdrip Primary I.V. Micro Pump Set, Vented, 102 Inch;
w) Latex-Free Soluset Microdrip 150 mL Burette Micro Pump Set, Vented, 124 Inch;
x) Latex-Free Specialty I.V. Pump Set-HB, Convertible Pin, 105 Inch;
y) LifeShield Latex-Free HEMA Blood PlumSet, Nonvented,110 Inch;
z) LifeShield Latex-Free Hemoset 100 mL Burette I.V. PlumSet, Nonvented, 105 Inch;
aa) Latex-Free Primary I.V. PlumSet, Nonvented, 112 Inch;
bb) LifeShield Latex-Free Secondary I.V. PlumSet, Convertible Pin, 18 Inch;
cc) LifeShield Latex-Free Primary I.V. PlumSet, Nonvented, 104 Inch
dd) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
ee) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
ff) Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch;
gg) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
hh) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 Inch;
ii) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
jj) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 105 Inch;
kk) Latex-Free Soluset 150 mL Burette PlumSet, Convertible Pin, 114 Inch;
ll) LifeShield Latex-Free Microdrip Soluset 150 mL Burette PlumSet, Convertible Pin, 124 Inch;
mm) LifeShield Latex-Free HEMOSET, 100 mL Burette I.V. PlumSet, Nonvented, 141 Inch;
nn) Latex-Free Secondary I.V. PlumSet, Convertible Pin, 18 Inch;
oo) Latex-Free Nitroglycerin PlumSet, Convertible Pin, 107 Inch;
pp) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
qq) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
rr) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 139 Inch;
ss) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 112 Inch
tt) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
uu) LifeShield Latex-Free Microdrip Soluset  150 mL Burette PlumSet, Convertible Pin, 124 Inch;
vv) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 139 Inch;
ww) Latex-Free Microdrip Soluset 150 mL Burette Pump Set, Convertible Piercing Pin, 124 Inch;
xx) LifeShield Latex-Free Microdrip Soluset 150 mL Burette PlumSet, Convertible Pin, 124 Inch;
yy) LifeShield Latex-Free Soluset 150 mL Burette I.V. PlumSet, Convertible Pin, 114 Inch;
zz) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 139 Inch;
aaa) Latex-Free Nitroglycerin Primary I.V. Pump Set, Convertible Pin, 110 Inch;
bbb) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
ccc) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
ddd) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch;
eee) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch;
fff) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch;
ggg) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 Inch;
hhh) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
iii) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
jjj) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch;
kkk) LifeShield Latex-Free Fat Emulsion I.V. PlumSet, Convertible Pin, 104 Inch;
lll) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 112 Inch;
mmm) LifeShield Latex-Free 150 mL Burette PlumSet, Convertible Pin, 114 Inch;
nnn) LifeShield Latex-Free GemStar Primary Piggyback Pump Set-SL, Convertible Pin, 110 Inch;
ooo) Latex-Free GemStar Primary Piggyback I.V. Pump Set-SL;
ppp) Latex-Free Enteral PlumSet, Nonvented, 98 Inch;  

   qqq) Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
rrr) LifeShield Latex-Free Primary I.V. PlumSet, Nonvented, 113 Inch;
sss) LifeShield Latex-Free Nitroglycerin Primary I.V. PlumSet, Convertible Pin, 107 Inch;
ttt) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 118 Inch;
uuu) LifeShield Latex-Free Primary I.V. Plumset, Convertible Pin, 104 Inch;
vvv) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 124 Inch;
www) LifeShield Latex-Free 50 mL Burette PlumSet, Convertible Pin, 107 Inch;
aaaa) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 135 Inch;
bbbb) LifeShield Latex-Free Microdrip Soluset 100 mL Burette PlumSet, Convertible Pin, 121 1/2 Inch;
cccc) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 103 Inch;
dddd) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 110 Inch;
eeee) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 108 Inch;
ffff) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 137 Inch;
gggg) LifeShield Latex-Free Soluset 100 mL Burette PlumSet, Convertible Pin, 121 Inch;
hhhh) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch;
E) Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; 15 different sets listed.
a) Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch;
b) Latex-Free Secondary I.V. Set, Nonvented, 32 Inch;
c) Latex-Free Secondary I.V. Set, Convertible Pin, 35 Inch;
d) Latex-Free Secondary I.V. Set with Convertible Pin, 32 Inch;
e) Latex-Free Secondary I.V. Set, Nonvented, 35 Inch;
f) Latex-Free Midlength Secondary I.V. Set, 40 Inch;
g) LifeShield Latex-Free Secondary I.V. Set, Nonvented, 32 Inch;
h) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch;
i) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch;
j) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch;
k) LifeShield Latex-Free Secondary I.V. Set, Convertible Pin, 32 Inch;
l) ColorGard Latex-Free Midlength Secondary I.V. Set, Convertible Pin, 40 Inch;
m) ColorGard Latex-Free Midlength Secondary I.V. Set, Convertible Pin, 40 Inch;
n) ColorGard Latex-Free Midlength Secondary I.V. Set, Convertible Pin, 40 Inch;
o) Latex-Free Midlength Secondary I.V. Set, Convertible Pin, 40 Inch.
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;
e) LifeShield Latex-Free Microbore Extension Set, list 119580401, lots 87084NS, 88056NS, 88078NS, 89088NS, 89143NS, 89181NS;
f) LifeShield Latex-Free Microbore Extension Set with Clave, Locking Spin Collar "T" and Prepierced Injection Site, list 120530401, lots 86107NS, 87126NS, 88125NS;
g) LifeShield Latex-Free Macrobore Extension Set, 7 88030HG, 88031HG, 891045H, 891875H, 891885H, 900165H, 900175H, 901015H, 910235H, 911485H, 920225H, 920785H, 921485H, 930425H, 930925H, 931205H, 940835H;
h) LifeShield Latex-Free Microbore Extension Set, 7 Inch, list 121130402, lot 87127NS;
i) LifeShield Latex-Free Macrobore Extension Set, list 123120401, lots 891095H, 910555H, 960775H;
j) LifeShield Latex-Free Microbore Extension Set, list 123130402, lots 86002HG, 86044HG, 87012HG, 87119HG, 90016HG, 90081NS, 92144NS;
k) LifeShield Latex-Free Microbore Extension Set INT, 6 Inch, list 123320401, lot 931375H;
l) LifeShield Latex-Free Tri-Leg Microbore Extension Set, list 123340401, lots 880605H, 891895H, 930945H, 950675H;
m) LifeShield Latex-Free Tri-Leg Extension Set, list 123460401, lots 88122HG, 89115HG, 920815H;
n) LifeShield Latex-Free Microbore Extension Set, list 124390401, lot 88176HG;
o) LifeShield Latex-Free Extension Set, 6 Inch, list 191420448, lots 87188HG, 89021HG, 93025R5;
p) Sterile Latex-Free Microbore Extension Set, list 191700204, lot 89135HG;
q) Sterile Latex-Free Microbore Extension Set, list 191700404, lots 010115H, 892045H, 911495H, 930965H, 940855H;
r) Microbore Extension Set, list 191700415, lot 961935H;
s) LifeShield Latex-Free Macrobore Extension Set, 46 Inch, list 192220448, lots 921425H, 960425H;
t) LifeShield Latex-Free Y-Type Connecting Set, 9 Inch, list 193130448, lots 88138HG, 881405H, 941705H
u) LifeShield Latex-Free Macrobore Extension Set, list 193280448, lots 900545H, 910305H;
v) 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.
C) 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 **** expanded to include lots 010304W, 930454W, 930464W and 960514W ****;
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 **** expanded to include lots  020494, 930484W, 930904W, 931304W, 941094W, 950704W, 960964W and 960974W ****;
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, 960594W960744W, 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 85034HG, 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.
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 70,062,517 sets, 1,079,350 chambers.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. Catalog # 027819201.
CODE Lot Number 0304300106.
RECALLING FIRM/MANUFACTURER Cobe Cardiovascular, Inc, Arvada, CO.
REASON Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
VOLUME OF PRODUCT IN COMMERCE 60 units.
DISTRIBUTION MN, NE, and OK.


PRODUCT a) Medamicus FlowGuard 16FR Valved Peelable Introducer Kit, Catalog Number 10532-011.
b) Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010.  
c) Angio Dynamics 14F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507601.
d) Angio Dynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602.
e) Angio Dynamics 16F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507603.
f) Medamicus FlowGuard 16FR Valved Peelable Introducer Kit, Catalog Number 10684-003.
g) Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011.

CODE a) Lot Number W23152;
b) Lot Number W23155;
c) Lot Numbers W24305, W24310, and W24311;
d) Lot Numbers W24306 and W24313;
e) Lot Numbers W24307, W24316, and W24317;
f) Lot Number W24369;
g) Lot Number W24540.
RECALLING FIRM/MANUFACTURER MedAmicus, Inc., Plymouth, MN.

REASON Stability testing, after accelerated aging of the device, shows that the handle of device does not meet strength specifications.
VOLUME OF PRODUCT IN COMMERCE 8,467 units.
DISTRIBUTION GA, MO, NY, and NC.


PRODUCT Misys Laboratory System.
CODE Version 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Abnormal results are flagged as normal.
VOLUME OF PRODUCT IN COMMERCE 1.
DISTRIBUTION NE.


PRODUCT Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit. Catalog # FR-8050.
CODE Lot #204016, Exp 09 NOV 02.
RECALLING FIRM/MANUFACTURER PerkinElmer Life Sciences, Inc., Norton, OH.
REASON The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.
VOLUME OF PRODUCT IN COMMERCE 10 kits.
DISTRIBUTION CA.


PRODUCT Misys Laboratory System using Microbiology versions 5.2 (build 4 and higher), 5.23 and 5.3.
CODE All codes.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Susceptibility comments are ommited from Microbiology cumulative reports.
VOLUME OF PRODUCT IN COMMERCE 471.
DISTRIBUTION Nationwide and Internationally,


PRODUCT Acuson Cypress Echocardiography System, Imaging System. Catalog # 8264604.
CODE Serial numbers 70000 through 72000.
RECALLING FIRM/MANUFACTURER Siemans Medical Solutions USA, Inc., Plymouth Meeting, PA.
REASON Software problem - loss of data.
VOLUME OF PRODUCT IN COMMERCE 1,540 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Axiom Sensis. Programmable Diagnostic Computer.
CODE Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, USA, Inc., Malvern, PA.
REASON Software problem - erroneous results or system crashes.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MA, and MI.


PRODUCT Deltec CASS-Prizm PCS II Ambulatory Infusion Pump with Revision E Software.  
CODE Pump Serial numbers 658825, 658837, 658840, 658842, 658844 - 658865, 658867, 658869 - 658896, 658898 - 658918, 658920 - 658936, 658941, 658943 - 658947, 658949, 662473 - 662477, 662483, 662485, 662488 - 662490, and 662635 - 662659.
RECALLING FIRM/MANUFACTURER Deltec, Inc., St. Paul, MN.
REASON Pump keyboard entries by the patient can result in the patient having unintended access to programming screens and result in improper drug dosage.
VOLUME OF PRODUCT IN COMMERCE 135 pumps.
DISTRIBUTION NC, and WA.


PRODUCT A.R.C. Laser Photolysis Probes/Handpieces. Catalog Number LY11002.
CODE Part Number: 1A55LM02.
RECALLING FIRM/MANUFACTURER A. R. C. Laser Corp., Salt Lake City, UT.
REASON Product may not have been properly sterilized.
VOLUME OF PRODUCT IN COMMERCE 370 units.
DISTRIBUTION IN, NY, PA, and TX.


PRODUCT CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a "zig" pattern. The number of zigs can be varied and will impact the strength of the stent as well as the eventual diameter and percent stent shortening. CP stents are sold either sterile or non-sterile, and sold in different lengths.
CODE All lots produced.
RECALLING FIRM/MANUFACTURER Numed Inc., Hopkinton, NY.
REASON Lacks a 510k clearance for marketing.
VOLUME OF PRODUCT IN COMMERCE 169 units.
DISTRIBUTION Nationwide.


PRODUCT Axiom Aristos X-Ray System.
CODE Part numbers 5895003 and 7414803. Serial numbers 01001, 01170, 01219, 01221, and 01030.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON Software malfunction. May indicate that the image is flipped when it is not.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION FL, MO, OK, and CO.


PRODUCT 3D Ceiling Suspension.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON The back up safety catch may not function properly.
VOLUME OF PRODUCT IN COMMERCE 3,504 units.
DISTRIBUTION Nationwide


PRODUCT CryoValve Allograft Aortic Valve and Conduit.
CODE Donor #66810, Device Serial #8100262, Model #AV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy..
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.


PRODUCT a) Clinitron CII Air Fluidized Therapy unit. b) Clinitron Up-Lift Air Fluidized Therapy unit.
CODE
a) Model CII, Serial # CC (all numeric codes). b) Model: Uplift, Serial # CH (all numeric codes).
RECALLING FIRM/MANUFACTURER Hill-Rom Manufacturing, Inc., Charleston, SC.
REASON Malfunction of side-rail latching pin coupled with inadequate directions for use.
VOLUME OF PRODUCT IN COMMERCE 122 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Nipro SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set.  CODE All catalog numbers and all lot numbers distributed between 10/24/2001 and 11/01/2002.
RECALLING FIRM/MANUFACTURER Nipro Corp, Miami, FL.
REASON Air or fluid leakage at the hub/needle junction.
VOLUME OF PRODUCT IN COMMERCE 6,984,000.
DISTRIBUTION Nationwide and Canada.


PRODUCT Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055.
CODE Lot No. 00008066; Expiration Date: 08-11-2001.
RECALLING FIRM/MANUFACTURER Zeus Scientific, Inc., Branchburg, NJ.
REASON Mix-up between low positive and negative controls.
VOLUME OF PRODUCT IN COMMERCE 15 kits.
DISTRIBUTION NJ.


PRODUCT a) Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays.
b) Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.  
c) Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.
CODE
a) Lots: #112770, Exp 6/14/03, and #116017, Exp 7/4/03;
b) Lots: #112785, Exp 6/14/03, and #116002, Exp 7/4/03;
c) Lot: # 116020, Exp 7/4/03.
RECALLING FIRM/MANUFACTURER PerkinElmer Life Sciences, Inc., Norton, OH.
REASON The device is not stable throughout its labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE 233 kits.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Magnetom Symphony/Sonata, OR Table.

CODE Serial Numbers 021107 and 021941.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON OR Table stops during the transfer of the table to the MR system and will not move.
VOLUME OF PRODUCT IN COMMERCE 2.
DISTRIBUTION CA, and TX.


PRODUCT Soft Contact Lenses (toric) packaged under the following labels: CV/ENCORE toric (methafilcon A) and ONEVUE 55 toric (methafilcon A) flexible wear.
CODE There are 768 lot numbers as follows: 3669001157, 3669001465, 3669001756, 3669001960, 3669002711, 3669002714, 3669002816, 3669003208, 3669003214, 3669500011, 3669500414, 3669500514, 3779000756, 3779001722, 3779002117, 3779002513, 3779002911, 3779003020, 3779003624, 3779003906, 3779005316, 3779500013, 3779500120, 3890000722, 3890001706, 3891001712, 3892000954, 3892001402, 3892001414, 3892001712, 3893001417, 3893001611, 3893001711, 3893002612, 3893002613, 3893002712, 3893003020, 3893003107, 3893003302, 3893003614, 3893004706, 3893004806, 3893500111, 3893500702, 3893500802, 3893500902, 3894001058, 3894001560, 3894001654, 3894002213, 3894002607, 3894002610, 3894002811, 3894003005, 3894004306, 3894004502, 3894004904, 3894005004, 3894500205, 3894500310, 3894500311, 3894500313, 3894500402, 3894500411, 3894500511, 3894500704, 3894500706, 3895001456, 3895002758, 3895002855, 3895003024, 3895003220, 3895003315, 3895003320, 3895003514, 3895003614, 3895003660, 3895004312, 3895004512, 3895004807, 3895004907, 3895005210, 3895005403, 3895005904, 3895006004, 3895006305, 3895006405, 3895006406, 3895006505, 3895006808, 3895500112, 3895500114, 3895500212, 3895500214, 3895500360, 3895500607, 3895500608, 3895500656, 3895500708, 3895500805, 3895500806, 3895500808, 3895500906, 3895501006, 3895501104, 3895501106, 3895501206, 3895501306, 3896001066, 3896001256, 3896001458, 3896001751, 3896001912, 3896002309, 3896002903, 3896003300, 3896003400, 3896003500, 3896500112, 3896500200, 3896500403, 3897000656, 3897002209, 3897002224, 3897002506, 3897002808, 3897002814, 3897002820, 3897003904, 3897500008, 3897500106, 3898000756, 3901001610, 3903000757, 3903000857, 3903001051, 3903002411, 3903002602, 3903002814, 3903003707, 3903003713, 3903003807, 3903500007, 3903500107, 3903500214, 3903500311, 3904000402, 3904000561, 3904000657, 3904001251, 3904001356, 3904001717, 3904002060, 3904002313, 3904003018, 3904003102, 3904003202, 3904003204, 3904500002, 3904500103, 3904500203, 3904500213, 3904500305, 3905001157, 3905001257, 3905001665, 3905001852, 3905002026, 3905002056, 3905003321, 3905004115, 3905004260, 3905004455, 3905004505, 3905004615, 3905004705, 3905004911, 3905004914, 3905005011, 3905005014, 3905005111, 3905005114, 3905005124, 3905005602, 3905005702, 3905005724, 3905005802, 3905006316, 3905006416, 3905007506, 3905007812, 3905500017, 3905500105, 3905500117, 3905500210, 3905500410, 3905500411, 3905500414, 3905500515, 3905500607, 3905500616, 3905500708, 3905500716, 3905500720, 3905501004, 3906001552, 3906002614, 3906002714, 3907001260, 3907003006, 3907003511, 3907003607, 3907003614, 3907003714, 3907003716, 3907003816, 3907004112, 3907004308, 3907004424, 3907004524, 3907005410, 3907005710, 3907500011, 3907500210, 3907500324, 3911001411, 3912001262, 3912001265, 3912001905, 3912002224, 3912003400, 3912003611, 3912004007, 3912004107, 3912004207, 3912500011, 3912500107, 3913001255, 3913001460, 3913001462, 3913002205, 3913002814, 3913002910, 3913003010, 3913003110, 3913500105, 3913500205, 3913500308, 3914001462, 3914001923, 3914002155, 3914002165, 3914002255, 3914003160, 3914003311, 3914003322, 3914003411, 3914004513, 3914004524, 3914004613, 3914004624, 3914004907, 3914005007, 3914005116, 3914005205, 3914005305, 3914005405, 3914005505, 3914005605, 3914006614, 3914006702, 3914006703, 3914006902, 3914007408, 3914007508, 3914007508, 3914500011, 3914500105, 3914500111, 3914500205, 3914500308, 3914500313, 3914500413, 3914500903, 3915000862, 3915001060, 3915001265, 3915001453, 3915001455, 3915001654, 3915002605, 3915500065, 3915500205, 3916000851, 3916002513, 3916002602, 3916002702, 3916005504, 3916500204, 3921001051, 3921003118, 3921003218, 3921004000, 3921004024, 3921004124, 3921004212, 3921004224, 3921004312, 3921004414, 3921004606, 3921005220, 3921005311, 3921500212, 3921500224, 3921500312, 3921500314, 3921500324, 3921500412, 3921500512, 3922000926, 3922000960, 3922001907, 3922002017, 3922002052, 3922002224, 3922002508, 3922003416, 3922004016, 3922500306, 3922500316, 3922500424, 3923000857, 3923001960, 3923002155, 3923002360, 3923002551, 3923003152, 3923004517, 3923004617, 3923004717, 3923005005, 3923005105, 3923006602, 3923006613, 3923006813, 3923007307, 3923007322, 3923007407, 3923007422, 3923007914, 3923008014, 3923008108, 3923008114, 3923008208, 3923008308, 3923008406, 3923008412, 3923008506, 3923008610, 3923008612, 3923008920, 3923009010, 3923009210, 3923011016, 3923011216, 3923011316, 3923500151, 3923500152, 3923500311, 3923500317, 3923500407, 3923500417, 3923500505, 3923500507, 3923500513, 3923500517, 3923500622, 3923500705, 3923500722, 3923500805, 3923500906, 3923500910, 3923500914, 3923501006, 3923501010, 3923501014, 3923501106, 3923501110, 3923501210, 3923501312, 3923501416, 3923501516, 3924001051, 3924001154, 3924001455, 3924001558, 3924002304, 3924004100, 3924500208, 3925002100, 3925002107, 3925002513, 3925002624, 3925003120, 3925003416, 3925004011, 3925004510, 3925500116, 3927000865, 3930001205, 3930001305, 3930002409, 3930002712, 3931002206, 3931002812, 3932002118, 3932002801, 3932003205, 3932003305, 3932003708, 3932004116, 3932006700, 3932500016, 3932500105, 3932500201, 3932500212, 3932500400, 3932500500, 3933000564, 3933001405, 3933002220, 3933002706, 3933500005, 3933500300, 3933500400, 3934000805, 3934002706, 3934002904, 3934003012, 3939002914, 3939003106, 3939003812, 3939004120, 3940000957, 3940001152, 3940001909, 3940002305, 3940002410, 3940002914, 3940003908, 3940500108, 3940500114, 3941002258, 3941002452, 3941002651, 3941002665, 3941002955, 3941003518, 3941003719, 3941003722, 3941004824, 3941004920, 3941004924, 3941005009, 3941005020, 3941005109, 3941005220, 3941005710, 3941005712, 3941005804, 3941005812, 3941005904, 3941006004, 3941006010, 3941006106, 3941006108, 3941006610, 3941006700, 3941007000, 3941500216, 3941500322, 3941500410, 3941500508, 3941500510, 3941500511, 3941500520, 3941500524, 3941500608, 3941500620, 3941500708, 4308001960, 4308002711, 4308002816, 4308003214, 4308500114, 4308500214, 4309002513, 4309003624, 4314001611, 4314002612, 4314003020, 4314003202, 4314003614, 4314004706, 4314500006, 4314500220, 4315001560, 4315002213, 4315002611, 4315004306, 4315500102, 4315500210, 4315500310, 4316002855, 4316003024, 4316003124, 4316003220, 4316003314, 4316003320, 4316003414, 4316004312, 4316004412, 4316004807, 4316004907, 4316005904, 4316006306, 4316006408, 4316006506, 4316006608, 4316500014, 4316500108, 4316500204, 4316500306, 4317001912, 4317002309, 4317003200, 4317500160, 4318002109, 4318002209, 4318002224, 4318002820, 4318500014, 4323002411, 4324000402, 4324001560, 4324003102, 4324500260, 4325004255, 4325004260, 4325004911, 4325004914, 4325005107, 4325005114, 4325005124, 4325005702, 4325005802, 4325006216, 4325006316, 4325006810, 4325006910, 4325006920, 4325007108, 4325007208, 4325007812, 4325500107, 4325500111, 4325500124, 4325500255, 4325500360, 4326000960, 4326002508, 4326002614, 4326002714, 4327001260, 4327004424, 4327005410, 4332002224, 4332003611, 4332004107, 4333001360, 4333002814, 4333002910, 4333003010, 4333500160, 4334002155, 4334002165, 4334003160, 4334003311, 4334004524, 4334006614, 4334006902, 4334007408, 4334007508, 4334500124, 4334500224, 4335001060, 4335001265, 4335001355, 4336002513, 4336002602, 4341004024, 4341004212, 4341004414, 4341005220, 4342002508, 4342003416, 4342500106, 4343002160, 4343002511, 4343006602, 4343006813, 4343007007, 4343007107, 4343007914, 4343008014, 4343008306, 4343008406, 4343008512, 4343008612, 4343008710, 4343008920, 4343009010, 4343010916, 4343500007, 4343500160, 4343500320, 4344002109, 4344004100, 4344500265, 4344500304, 4344500355, 4344500365, 4344500455, 4344500465, 4345002513, 4345003120, 4350001060, 4350002409, 4350002712, 4351002206, 4351500060, 4351500106, 4351500112, 4351500160, 4351500212, 4352001060, 4352003708, 4352003808, 4352003912, 4352004012, 4352006500, 4352006600, 4352006700, 4352500008, 4352500160, 4353002220, 4353002706, 4353003000, 4353003200, 4353500160, 4354003012, 4360001155, 4360002814, 4360002914, 4360003808, 4360500108, 4360500109, 4360500110, 4361002665, 4361004724, 4361004824, 4361004920, 4361005024, 4361005109, 4361005216, 4361005712, 4361005804, 4361005911, 4361006008, 4361006010, 4361006210, 4361006510, 4361006700, 4361006800, 4361500009, 4361500016, 4361500120, 4361500300, 4361500365, 4361500455, 4361500555, 6591001465, 6591001960, 6598002213, 6598002611, 6599002855, 6599003315, 6599003414, 6599004312, 6599005904, 6608004355, 6608004911, 6608005602, 6608007108, 6609000960, 6616001460, 6616002205, 6616002910, 6617002155, 6617003411, 6617007408, 6617500005, 6617500005, 6618001355, 6626001960, 6626005005, 6626008920, 6626010916, 6627001455, 6627004100, 6627500065, 6634001805, 6634001905, 6635003205, 6635003708, 6635006600, 6636001255, 6636003000, 6636003200, 6636500006, 6636500006, 6643001155, 6643001265, 6643002814, 6644002665, 6644002955, 6644004724, 6644005020, 6644005712, 6644005712, 6644005804, 6644006110, 6644006700, 9198000601, 9198000613, 9198000712, 9198000812, 9199000713, 9201000313, 9215001213, 9215001712, 9215001812, 9215001912, 9215002012, 9801001851, 9804001706, 9807003614, 9809003320, 9811002224, 9814001610, 9818001157, 9818001864, 9820004524, 9825004007, 9838003516, 9843002409, 9844001905, 9853002305.
RECALLING FIRM/MANUFACTURER Coopervision, Inc., Scottsville, NY.
REASON The actual sphere power of the lens is lower than the labeled value.
VOLUME OF PRODUCT IN COMMERCE 23,762 6-packs / 76,748 singles (trial lenses).
DISTRIBUTION Nationwide, and Internationally.


PRODUCT V*CARE, Infant Resuscitator, with 40 cm H_O Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. CODE Lot numbers 3332838D, 333238D5; Product Codes: VN3100OCP, VN3100MC, VN3100OCP-B, VN3100MCP-2 and VN3100OCB.
RECALLING FIRM/MANUFACTURER Ventlab Corporation, Mocksville, NC.
REASON Printed bag with instructions to verify the pressure with a "certified manometer" was omitted in some of the product.
VOLUME OF PRODUCT IN COMMERCE 9 cases (10 units per case).
DISTRIBUTION CA.


PRODUCT a) Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.
b) Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TLC10, staple size:

3 mm x 3.85 mm.
CODE
a) Lot number: T4W32E, Exp 2008-03;
b) Lot number: T4W128, Exp 2008-03.
RECALLING FIRM/MANUFACTURER Ethicon Endo-Surgery, Cincinnati, OH.
REASON The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
VOLUME OF PRODUCT IN COMMERCE 240 instruments.
DISTRIBUTION Nationwide.


PRODUCT ProLong Continuous Nerve Block Set.
CODE All manufacturing codes were recalled. Model numbers: PL-50, PL-100.
RECALLING FIRM/MANUFACTURER Life-Tech International, Inc, Stafford, TX.
REASON Catheter does not fit through the needle resulting in delay of medical procedure.
VOLUME OF PRODUCT IN COMMERCE 207 boxes of 10 each.
DISTRIBUTION CA, MN, TX, FL, and UT.


PRODUCT a) Mitek Products. Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325.
b) Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420.
CODE
a) Lot number 0207145 Exp 2007-7;
b) Lot number 0207146 Exp 2007-7.
RECALLING FIRM/MANUFACTURER Mitek Worldwide, Norwood, MA.
REASON Mislabeled - Incorrect Screw Size. The unit labeled 7x25 mm screw may be a 8x20 mm; and the unit labeled 8x20 mm may be a 7x25 mm.
VOLUME OF PRODUCT IN COMMERCE 72.
DISTRIBUTION CA, FL, NJ, MO, NY, OR, TX, VA, Argentina, Australia, Japan, Arab, Emirates, Portugal, and Spain.


PRODUCT Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number 6557.
CODE Lot number 5404484.
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Natick, MA.
REASON Mislabeled; Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm.
VOLUME OF PRODUCT IN COMMERCE 23 units.
DISTRIBUTION CO, FL, IA, IL, NY, VT, TX, Singapore, and Korea.