| | Class 1 Device Recall Cardinal Health Presource |  |
| Date Initiated by Firm | September 24, 2026 |
| Date Posted | November 02, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0212-2027 |
| Recall Event ID |
100058 |
| Product Classification |
Anesthesia kit - Product Code OFQ
|
| Product | Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT, ANESTHESIA, CATALOG # IVSVM41612;
2) KIT, ANESTHESIA, CATALOG # IVSVM41611;
3) KIT, ANESTHESIA, CATALOG # IVSVM41610;
4) KIT, ANESTHESIA, CATALOG # IVSVM41669;
5) KIT, ANESTHESIA, CATALOG # IVSVM41668;
6) KIT, ANESTHESIA, CATALOG # IVSVM41667;
7) KIT, ANESTHESIA, CATALOG # IVSVM4166C;
8) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS16;
9) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS15;
10) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS14;
11) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS13;
12) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS12;
13) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS11;
14) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS10;
15) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC9;
16) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC8;
17) KIT, ANESTHESIA, CATALOG # IVSVM4166B;
18) KIT, ANESTHESIA, CATALOG # IVSVM41666;
19) OPEN HEART ANESTHESIA, , CATALOG # PC4KOHSC7;
20) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC6;
21) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC5;
22) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC4;
23) OPEN HEART ANESTHESIA KIT, CATALOG # PC4KOHSCB;
24) OPEN HEART ANESTHESIA KIT, CATALOG # PC4KOHSCA;
25) KIT,ANESTHESIA, CATALOG # PZVMANMOP;
26) KIT, ANESTHESIA, CATALOG # IVSVM41665;
27) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC2;
28) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCG;
29) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCF;
30) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE;
31) OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE;
32) KIT, ANESTHESIA , CATALOG # IVSVM4166A;
33) KIT,ANESTHESIA , CATALOG # PZVMANMO3;
34) KIT,OPEN HEART ANESTHESIA , CATALOG # PC4KOHSCD;
35) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCD;
36) KIT,ANESTHESIA , CATALOG # PZVMANMOQ;
37) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCC. |
| Code Information |
CATALOG # IVSVM41612, GTIN 10888439827576 (ea) 50888439827574 (cs), LOT #433785;
CATALOG # IVSVM41612, GTIN 10888439827576 (ea) 50888439827574 (cs), LOT #433785;
CATALOG # IVSVM41612, GTIN 10888439827576 (ea) 50888439827574 (cs), LOT #433785;
CATALOG # IVSVM41611, GTIN 10888439795370 (ea) 50888439795378 (cs), LOT #408485;
CATALOG # IVSVM41610, GTIN 10888439725094 (ea) 50888439725092 (cs), LOT #381796;
CATALOG # IVSVM41610, GTIN 10888439725094 (ea) 50888439725092 (cs), LOT #381796;
CATALOG # IVSVM41610, GTIN 10888439725094 (ea) 50888439725092 (cs), LOT #381796;
CATALOG # IVSVM41669, GTIN 10888439616132 (ea) 50888439616130 (cs), LOT #326127;
CATALOG # IVSVM41668, GTIN 10888439360172 (ea) 50888439360170 (cs), LOT #166245;
CATALOG # IVSVM41668, GTIN 10888439360172 (ea) 50888439360170 (cs), LOT #166245;
CATALOG # IVSVM41668, GTIN 10888439360172 (ea) 50888439360170 (cs), LOT #166245;
CATALOG # IVSVM41667, GTIN 10888439315936 (ea) 50888439315934 (cs), LOT #149124;
CATALOG # IVSVM41667, GTIN 10888439315936 (ea) 50888439315934 (cs), LOT #149124;
CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #105414;
CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #191135;
CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #191135;
CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #227900;
CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #227900;
CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #254339;
CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #296385;
CATALOG # PC4KOHS16, GTIN 10887488329437 (ea) 50887488329435 (cs), LOT #397529;
CATALOG # PC4KOHS15, GTIN 10887488316734 (ea) 50887488316732 (cs), LOT #386921;
CATALOG # PC4KOHS14, GTIN 10887488305028 (ea) 50887488305026 (cs), LOT #376919;
CATALOG # PC4KOHS13, GTIN 10887488271569 (ea) 50887488271567 (cs), LOT #356104;
CATALOG # PC4KOHS13, GTIN 10887488271569 (ea) 50887488271567 (cs), LOT #356104;
CATALOG # PC4KOHS12, GTIN 10887488259666 (ea) 50887488259664 (cs), LOT #348361;
CATALOG # PC4KOHS11, GTIN 10887488255316 (ea) 50887488255314 (cs), LOT #343851;
CATALOG # PC4KOHS10, GTIN 10887488233680 (ea) 50887488233688 (cs), LOT #328666;
CATALOG # PC4KOHSC9, GTIN 10887488227016 (ea) 50887488227014 (cs), LOT #325958;
CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), LOT #300901;
CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), LOT #300901;
CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), LOT #300901;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #295338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #295338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #295338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #295338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #313443;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #313443;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #313443;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #313443;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #327618;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #327618;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #327618;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #347530;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #347530;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #354960;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #354960;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #354960;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #387338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #387338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #387338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #387338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #387338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #387338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #387338;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #394184;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #394184;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #423736;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #444959;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #450588;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #450588;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #450588;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #450588;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #450588;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #450588;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #481517;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #496125;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #496125;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #496125;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #516187;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #516187;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #548736;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #548736;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #548736;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #570203;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #570203;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #590995;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #590995;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #604610;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #604610;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #604610;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #622735;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #622735;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #622735;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #622735;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #650954;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #650954;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #650954;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #668925;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #668925;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #668925;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #668925;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #668925;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #691487;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #691487;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #691487;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #691487;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #719564;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #719564;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #751357;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #751357;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #751357;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #793325;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #793325;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #832912;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #832912;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #832912;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #832912;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #868231;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #868231;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #868231;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #868231;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #911496;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #911496;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #935218;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #935218;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #958626;
CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #958626;
CATALOG # IVSVM41666, GTIN 10887488167619 (ea) 50887488167617 (cs), LOT #280453;
CATALOG # IVSVM41666, GTIN 10887488167619 (ea) 50887488167617 (cs), LOT #280453;
CATALOG # PC4KOHSC7, GTIN 10887488151236 (ea) 50887488151234 (cs), LOT #269991;
CATALOG # PC4KOHSC6, GTIN 10887488123172 (ea) 50887488123170 (cs), LOT #245270;
CATALOG # PC4KOHSC6, GTIN 10887488123172 (ea) 50887488123170 (cs), LOT #245270;
CATALOG # PC4KOHSC5, GTIN 10887488098807 (ea) 50887488098805 (cs), LOT #230582;
CATALOG # PC4KOHSC4, GTIN 10887488097046 (ea) 50887488097044 (cs), LOT #230414;
CATALOG # PC4KOHSC4, GTIN 10887488097046 (ea) 50887488097044 (cs), LOT #230414;
CATALOG # PC4KOHSCB, GTIN 8854251392788 (ea) 58854251392783 (cs), LOT #61527;
CATALOG # PC4KOHSCB, GTIN 8854251392788 (ea) 58854251392783 (cs), LOT #65344;
CATALOG # PC4KOHSCA, GTIN 8854251307195 (ea) 58854251307190 (cs), LOT #52252;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #369727;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #369727;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #390874;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #390874;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #413394;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #446661;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #446661;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #495488;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #495488;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #495488;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #515031;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #515031;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #522231;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #526229;
CATALOG # PZVMANMOP, GTIN 8854250199418 (ea) 58854250199413 (cs), LOT #537240;
CATALOG # IVSVM41665, GTIN 885425995618 (ea) 50885425995613 (cs), LOT #146215;
CATALOG # PC4KOHSC2, GTIN 885425949192 (ea) 50885425949197 (cs), LOT #106880;
CATALOG # PC4KOHSC2, GTIN 885425949192 (ea) 50885425949197 (cs), LOT #106880;
CATALOG # PC4KOHSC2, GTIN 885425949192 (ea) 50885425949197 (cs), LOT #106880;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), LOT #40499;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), LOT #67243;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), LOT #102305;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), LOT #102305;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), LOT #109687;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), LOT #109687;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), LOT #149634;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), LOT #149634;
CATALOG # PC4KOHSCF, GTIN 885425828084 (ea) 50885425828089 (cs), LOT #26708;
CATALOG # PC4KOHSCF, GTIN 885425828084 (ea) 50885425828089 (cs), LOT #26708;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), LOT #999195;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), LOT #24052;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), LOT #152489;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), LOT #152489;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), LOT #152489;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), LOT #152489;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #973907;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #973907;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #973907;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #973907;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #976493;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #976493;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #6665;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #6665;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #14495;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #14495;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #27133;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #158124;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #158124;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #184956;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #192212;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #192212;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #214030;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #244624;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #251126;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #254606;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #254606;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #254606;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #254606;
CATALOG # IVSVM4166A, GTIN 885425727240 (ea) 50885425727245 (cs), LOT #292112;
CATALOG # PZVMANMO3, GTIN 885425681146 (ea) 50885425681141 (cs), LOT #948109;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), LOT #928799;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), LOT #928799;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), LOT #134674;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), LOT #134674;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), LOT #134674;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), LOT #134674;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), LOT #134674;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), LOT #139836;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #855521;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #862959;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #862959;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #862959;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #862959;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #866799;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #866799;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #875809;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #882379;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #882379;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #894755;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #906469;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #932010;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #941056;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #948108;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #948108;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #948108;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #961332;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #961332;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #961332;
CATALOG # PZVMANMOQ, GTIN 885425345543 (ea) 50885425345548 (cs), LOT #961332;
CATALOG # PC4KOHSCC, GTIN 885425115283 (ea) 50885425115288 (cs), LOT #82778;
CATALOG # PC4KOHSCC, GTIN 885425115283 (ea) 50885425115288 (cs), LOT #94566;
CATALOG # PC4KOHSCC, GTIN 885425115283 (ea) 50885425115288 (cs), LOT #113690;
CATALOG # PC4KOHSCC, GTIN 885425115283 (ea) 50885425115288 (cs), LOT #113690;
CATALOG # PC4KOHSCC, GTIN 885425115283 (ea) 50885425115288 (cs), LOT #122128.
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| FEI Number |
3001236905
|
Recalling Firm/ Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan
IL
60085-8337
|
| For Additional Information Contact | Cardinal Health Quality Systems 800-292-9332 |
Manufacturer Reason for Recall | Kits contain infusion sets which were recalled for performance issues. |
FDA Determined Cause 2 | Nonconforming Material/Component |
| Action | Cardinal Health issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 9/24/2026 via US Mail. The notice explained the issue and requested the discontinuation of the use of the affected BD Alaris Pump Infusion Sets as per the enclosed notice from Becton Dickinson.
The notice instructed the following:
If you locate affected product within your facility, please do the following:
1. QUARANTINE affected kits.
2. ALERT your clinicians of this action.
3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to
clinicians, instructing them to remove and discard the recalled component(s).
4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this
action and the completion of labeling product via fax to 614.652.9648.
Additional labels will be sent to your facility upon request. Please send an email to:
gmb-FieldCorrectiveAction@cardinalhealth.com
For component credit or replacement, please contact the following:
Hospitals Cardinal Customer Service at 866.551.0533
Distributors Distributor Management at 800.635.6021
Federal Government facilities Government Customer Service at 800.444.1166
Distributors were directed to notify their customers of the recall.
For questions contact: Cardinal Health Quality Systems at 800.292.9332. |
| Quantity in Commerce | 12358 kits |
| Distribution | US and Canada |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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