| | 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-0220-2027 |
| Recall Event ID |
100058 |
| Product Classification |
Labor and Delivery Kit - Product Code MLS
|
| Product | Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT,LABOR KIT, , CATALOG # MA1JV8300C;
2) KIT,LABOR KIT, , CATALOG # MA1JV8300B;
3) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATM3;
4) KIT,LABOR KIT, , CATALOG # MA1JV83001;
5) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATM2;
6) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATMN;
7) KIT,LABOR KIT, , CATALOG # MA1JV8300A;
8) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATMB;
9) LABOR, KIT , CATALOG # PBJVAD00S;
10) KIT,LABOR, , CATALOG # PL41OTHS4;
11) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATMA;
12) KIT,LABOR, , CATALOG # PL41OTHSV;
13) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATML;
14) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATMK;
15) KIT,LABOR KIT, , CATALOG # PBJVAD00X;
16) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATMJ;
17) LABOR KIT, ,KIT , CATALOG # PBJVAD00W;
18) LABOR KIT, ,KIT , CATALOG # PBJVAD00U;
19) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATMH;
20) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATMG;
21) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATM1;
22) KIT, VAGINAL DELIVERY , CATALOG # PL42VDATME;
23) KIT,LABOR, , CATALOG # PL41OTHSW;
24) LABOR KIT, KIT , CATALOG # PBJVAD00T;
25) LABOR, KIT , CATALOG # PBJVAD00T;
26) LABOR, , KIT , CATALOG # PBJVAD00T;
27) CENTER KIT , CATALOG # PL73FBDW5;
28) CENTER, KIT , CATALOG # PL73FBDW4;
29) CENTER, KIT , CATALOG # PL73FBDW3;
30) CENTER, KIT , CATALOG # PL73FBDW2;
31) KIT, CENTER,, CATALOG # PL73FBDW1;
32) KIT, CENTER,, CATALOG # PL73OTDW1;
33) KIT, CENTER,, CATALOG # PL73OTDWU;
34) KIT, CENTER,, CATALOG # PL73OTDWT;
35) KIT, CENTER,, CATALOG # PL73OTDWS. |
| Code Information |
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #500060;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #500060;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #500060;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #500060;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #519838;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #519838;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #541166;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #541166;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #541166;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #541166;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #561757;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #561757;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #561757;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #582974;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #605722;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #605722;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #605722;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #605722;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #630532;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #630532;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #649740;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #649740;
CATALOG #MA1JV8300C, GTIN 10887488483146 (ea) 50887488483144 (cs), LOT #676253;
CATALOG #MA1JV8300B, GTIN 10887488323428 (ea) 50887488323426 (cs), LOT #408506;
CATALOG #MA1JV8300B, GTIN 10887488323428 (ea) 50887488323426 (cs), LOT #408506;
CATALOG #MA1JV8300B, GTIN 10887488323428 (ea) 50887488323426 (cs), LOT #424817;
CATALOG #MA1JV8300B, GTIN 10887488323428 (ea) 50887488323426 (cs), LOT #451873;
CATALOG #MA1JV8300B, GTIN 10887488323428 (ea) 50887488323426 (cs), LOT #451873;
CATALOG #MA1JV8300B, GTIN 10887488323428 (ea) 50887488323426 (cs), LOT #451873;
CATALOG #MA1JV8300B, GTIN 10887488323428 (ea) 50887488323426 (cs), LOT #472033;
CATALOG #MA1JV8300B, GTIN 10887488323428 (ea) 50887488323426 (cs), LOT #472033;
CATALOG #PL42VDATM3, GTIN 10887488304687 (ea) 50887488304685 (cs), LOT #378304;
CATALOG #PL42VDATM3, GTIN 10887488304687 (ea) 50887488304685 (cs), LOT #378304;
CATALOG #MA1JV83001, GTIN 10887488268576 (ea) 50887488268574 (cs), LOT #356036;
CATALOG #MA1JV83001, GTIN 10887488268576 (ea) 50887488268574 (cs), LOT #356036;
CATALOG #MA1JV83001, GTIN 10887488268576 (ea) 50887488268574 (cs), LOT #356036;
CATALOG #MA1JV83001, GTIN 10887488268576 (ea) 50887488268574 (cs), LOT #356036;
CATALOG #MA1JV83001, GTIN 10887488268576 (ea) 50887488268574 (cs), LOT #356036;
CATALOG #PL42VDATM2, GTIN 10887488212449 (ea) 50887488212447 (cs), LOT #311891;
CATALOG #PL42VDATM2, GTIN 10887488212449 (ea) 50887488212447 (cs), LOT #311891;
CATALOG #PL42VDATM2, GTIN 10887488212449 (ea) 50887488212447 (cs), LOT #311891;
CATALOG #PL42VDATMN, GTIN 10887488165011 (ea) 50887488165019 (cs), LOT #324429;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #221591;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #221591;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #221591;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #221591;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #233296;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #233296;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #233296;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #252473;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #252473;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #274401;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #274401;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #274401;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #274401;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #274401;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #274401;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #274401;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #274401;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #274401;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #295340;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #295340;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #309090;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #309090;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #309090;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #320084;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #327759;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #327759;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #345386;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #358433;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #358433;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #358433;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #358433;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #358433;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #377461;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #377461;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #377461;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #377461;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #391108;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #391108;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #391108;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #391108;
CATALOG #MA1JV8300A, GTIN 10887488061689 (ea) 50887488061687 (cs), LOT #391108;
CATALOG #PL42VDATMB, GTIN 8854251488672 (ea) 58854251488677 (cs), LOT #815004;
CATALOG #PL42VDATMB, GTIN 8854251488672 (ea) 58854251488677 (cs), LOT #815004;
CATALOG #PBJVAD00S, GTIN 8854251374814 (ea) 58854251374819 (cs), LOT #96940;
CATALOG #PBJVAD00S, GTIN 8854251374814 (ea) 58854251374819 (cs), LOT #96940;
CATALOG #PL41OTHS4, GTIN 8854251296116 (ea) 58854251296111 (cs), LOT #739011;
CATALOG #PL41OTHS4, GTIN 8854251296116 (ea) 58854251296111 (cs), LOT #739011;
CATALOG #PL42VDATMA, GTIN 8854251273698 (ea) 58854251273693 (cs), LOT #764603;
CATALOG #PL42VDATMA, GTIN 8854251273698 (ea) 58854251273693 (cs), LOT #799434;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #703867;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #718045;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #722172;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #722172;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #751701;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #751701;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #751701;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #757930;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #769962;
CATALOG #PL41OTHSV, GTIN 8854251177231 (ea) 58854251177236 (cs), LOT #769962;
CATALOG #PL42VDATML, GTIN 885425992198 (ea) 50885425992193 (cs), LOT #193818;
CATALOG #PL42VDATML, GTIN 885425992198 (ea) 50885425992193 (cs), LOT #204464;
CATALOG #PL42VDATML, GTIN 885425992198 (ea) 50885425992193 (cs), LOT #204464;
CATALOG #PL42VDATML, GTIN 885425992198 (ea) 50885425992193 (cs), LOT #248433;
CATALOG #PL42VDATML, GTIN 885425992198 (ea) 50885425992193 (cs), LOT #253705;
CATALOG #PL42VDATMK, GTIN 885425928630 (ea) 50885425928635 (cs), LOT #121460;
CATALOG #PL42VDATMK, GTIN 885425928630 (ea) 50885425928635 (cs), LOT #132774;
CATALOG #PL42VDATMK, GTIN 885425928630 (ea) 50885425928635 (cs), LOT #140701;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #23421;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #33554;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #33554;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #33554;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #33554;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #33554;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #43203;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #49540;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #49540;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #57465;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #67261;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #67261;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #91489;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #91489;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #103954;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #130262;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #146244;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #173286;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #173286;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #173286;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #173286;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #173286;
CATALOG #PBJVAD00X, GTIN 885425805863 (ea) 50885425805868 (cs), LOT #198680;
CATALOG #PL42VDATMJ, GTIN 885425800899 (ea) 50885425800894 (cs), LOT #82497;
CATALOG #PBJVAD00W, GTIN 885425779133 (ea) 50885425779138 (cs), LOT #218461;
CATALOG #PBJVAD00W, GTIN 885425779133 (ea) 50885425779138 (cs), LOT #218461;
CATALOG #PBJVAD00W, GTIN 885425779133 (ea) 50885425779138 (cs), LOT #218461;
CATALOG #PBJVAD00U, GTIN 885425673134 (ea) 50885425673139 (cs), LOT #197672;
CATALOG #PBJVAD00U, GTIN 885425673134 (ea) 50885425673139 (cs), LOT #197672;
CATALOG #PBJVAD00U, GTIN 885425673134 (ea) 50885425673139 (cs), LOT #206659;
CATALOG #PBJVAD00U, GTIN 885425673134 (ea) 50885425673139 (cs), LOT #206659;
CATALOG #PBJVAD00U, GTIN 885425673134 (ea) 50885425673139 (cs), LOT #206659;
CATALOG #PBJVAD00U, GTIN 885425673134 (ea) 50885425673139 (cs), LOT #206659;
CATALOG #PL42VDATMH, GTIN 885425670416 (ea) 50885425670411 (cs), LOT #32603;
CATALOG #PL42VDATMH, GTIN 885425670416 (ea) 50885425670411 (cs), LOT #32603;
CATALOG #PL42VDATMH, GTIN 885425670416 (ea) 50885425670411 (cs), LOT #32603;
CATALOG #PL42VDATMH, GTIN 885425670416 (ea) 50885425670411 (cs), LOT #32603;
CATALOG #PL42VDATMG, GTIN 885425572888 (ea) 50885425572883 (cs), LOT #905014;
CATALOG #PL42VDATMG, GTIN 885425572888 (ea) 50885425572883 (cs), LOT #905014;
CATALOG #PL42VDATMG, GTIN 885425572888 (ea) 50885425572883 (cs), LOT #905014;
CATALOG #PL42VDATMG, GTIN 885425572888 (ea) 50885425572883 (cs), LOT #934476;
CATALOG #PL42VDATMG, GTIN 885425572888 (ea) 50885425572883 (cs), LOT #951889;
CATALOG #PL42VDATMG, GTIN 885425572888 (ea) 50885425572883 (cs), LOT #972754;
CATALOG #PL42VDATMG, GTIN 885425572888 (ea) 50885425572883 (cs), LOT #998599;
CATALOG #PL42VDATMG, GTIN 885425572888 (ea) 50885425572883 (cs), LOT #998599;
CATALOG #PL42VDATMG, GTIN 885425572888 (ea) 50885425572883 (cs), LOT #998599;
CATALOG #PL42VDATM1, GTIN 885425540290 (ea) 50885425540295 (cs), LOT #875392;
CATALOG #PL42VDATME, GTIN 885425334776 (ea) 50885425334771 (cs), LOT #869818;
CATALOG #PL42VDATME, GTIN 885425334776 (ea) 50885425334771 (cs), LOT #869818;
CATALOG #PL42VDATME, GTIN 885425334776 (ea) 50885425334771 (cs), LOT #869818;
CATALOG #PL42VDATME, GTIN 885425334776 (ea) 50885425334771 (cs), LOT #879050;
CATALOG #PL42VDATME, GTIN 885425334776 (ea) 50885425334771 (cs), LOT #879050;
CATALOG #PL42VDATME, GTIN 885425334776 (ea) 50885425334771 (cs), LOT #893335;
CATALOG #PL42VDATME, GTIN 885425334776 (ea) 50885425334771 (cs), LOT #893335;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #784070;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #784070;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #784070;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #799430;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #799430;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #809338;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #809338;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #824874;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #824874;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #840214;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #840214;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #858782;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #858782;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #858782;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #858782;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #858782;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #858782;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #858782;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #878523;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #882411;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #894096;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #904576;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #904576;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #915474;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #915474;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #934509;
CATALOG #PL41OTHSW, GTIN 885425334660 (ea) 50885425334665 (cs), LOT #934509;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #128733;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #128733;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #146470;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #146470;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #146470;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #146470;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #155463;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #160016;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #167090;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #167090;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #168600;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #174272;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #174272;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #178681;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #178681;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #178681;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #189774;
CATALOG #PBJVAD00T, GTIN 885425212364 (ea) 50885425212369 (cs), LOT #189774;
CATALOG #PL73FBDW5, GTIN 382603511337 (ea) 50382603511332 (cs), LOT #119317;
CATALOG #PL73FBDW5, GTIN 382603511337 (ea) 50382603511332 (cs), LOT #119317;
CATALOG #PL73FBDW5, GTIN 382603511337 (ea) 50382603511332 (cs), LOT #119317;
CATALOG #PL73FBDW4, GTIN 382603461434 (ea) 50382603461439 (cs), LOT #115246;
CATALOG #PL73FBDW3, GTIN 382603417103 (ea) 50382603417108 (cs), LOT #110645;
CATALOG #PL73FBDW3, GTIN 382603417103 (ea) 50382603417108 (cs), LOT #110645;
CATALOG #PL73FBDW2, GTIN 382603368252 (ea) 50382603368257 (cs), LOT #107365;
CATALOG #PL73FBDW2, GTIN 382603368252 (ea) 50382603368257 (cs), LOT #107365;
CATALOG #PL73FBDW2, GTIN 382603368252 (ea) 50382603368257 (cs), LOT #107365;
CATALOG #PL73FBDW1, GTIN 382603349398 (ea) 50382603349393 (cs), LOT #105930;
CATALOG #PL73OTDW1, GTIN 382603325774 (ea) 50382603325779 (cs), LOT #103603;
CATALOG #PL73OTDW1, GTIN 382603325774 (ea) 50382603325779 (cs), LOT #103603;
CATALOG #PL73OTDW1, GTIN 382603325774 (ea) 50382603325779 (cs), LOT #103603;
CATALOG #PL73OTDW1, GTIN 382603325774 (ea) 50382603325779 (cs), LOT #103603;
CATALOG #PL73OTDWU, GTIN 382603276151 (ea) 50382603276156 (cs), LOT #100510;
CATALOG #PL73OTDWU, GTIN 382603276151 (ea) 50382603276156 (cs), LOT #100510;
CATALOG #PL73OTDWU, GTIN 382603276151 (ea) 50382603276156 (cs), LOT #100510;
CATALOG #PL73OTDWT, GTIN 382603166049 (ea) 50382603166044 (cs), LOT #994976;
CATALOG #PL73OTDWT, GTIN 382603166049 (ea) 50382603166044 (cs), LOT #994976;
CATALOG #PL73OTDWS, GTIN 382603112350 (ea) 50382603112355 (cs), LOT #991899;
CATALOG #PL73OTDWS, GTIN 382603112350 (ea) 50382603112355 (cs), LOT #991899.
|
| 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 | 47707 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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