| | Class 1 Device Recall Cardinal Health Presource |  |
| Date Initiated by Firm | September 23, 2026 |
| Date Posted | November 07, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0330-2027 |
| Recall Event ID |
100064 |
| Product Classification |
Tray, surgical - Product Code LRP
|
| Product | Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100,labeled as:
1) LDR,MUSC,KIT , CATALOG # MAT232105E;
2) LDR,MUSC,KIT , CATALOG # MAT232105F;
3) C SECTION ADMIT,KIT , CATALOG # MA1232105E;
4) KIT,NICU ADMIT, , CATALOG # BABMH5297F;
5) KIT,NICU ADMIT, , CATALOG # BABMH5297G;
6) KIT,NICU ADMIT, , CATALOG # BABMH5297H;
7) KIT,NICU ADMIT, , CATALOG # BABMH5297I;
8) KIT,NICU ADMIT, , CATALOG # BABMH52971;
9) KIT,NICU ADMIT, , CATALOG # BABMH52972;
10) KIT,OPEN HEART ANESTHESIA , CATALOG # PC4KOHSCD;
11) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE;
12) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCF;
13) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCG;
14) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC2;
15) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC4;
16) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC5;
17) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC6;
18) OPEN HEART ANESTHESIA, , CATALOG # PC4KOHSC7;
19) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC8;
20) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC9;
21) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS10;
22) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS11;
23) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS12;
24) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS13;
25) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS14;
26) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS15;
27) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS16;
28) NICU ADMIT, KIT , CATALOG # BABMH5297E;
29) NICU ADMIT, KIT , CATALOG # BABMH5297F;
30) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCA;
31) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCB;
32) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCC;
33) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCD;
34) OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE;
35) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSC1;
36) SPECIAL PROCEDURE KIT , CATALOG # SP1410346C;
37) SPECIAL PROCEDURE KIT , CATALOG # SP14103461;
38) SPECIAL PROCEDURE KIT , CATALOG # SP14103462;
39) SPECIAL PROCEDURE KIT , CATALOG # SP14103463;
40) SPECIAL PROCEDURE KIT , CATALOG # SP14103464. |
| Code Information |
CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E;
CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E;
CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E;
CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E;
CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # MA1232105E, GTIN 10887488366982 (ea) 50887488366980 (cs), WO # MA1232105E;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297G, GTIN 885425859934 (ea) 50885425859939 (cs), WO # BABMH5297G;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 885425937748 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297H, GTIN 10885425937745 (ea) 50885425937743 (cs), WO # BABMH5297H;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH5297I, GTIN 10887488605067 (ea) 50887488605065 (cs), WO # BABMH5297I;
CATALOG # BABMH52971, GTIN 10888439215199 (ea) 50888439215197 (cs), WO # BABMH52971;
CATALOG # BABMH52972, GTIN 10888439483017 (ea) 50888439483015 (cs), WO # BABMH52972;
CATALOG # BABMH52972, GTIN 10888439483017 (ea) 50888439483015 (cs), WO # BABMH52972;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), WO # PC4KOHSCD;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), WO # PC4KOHSCE;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), WO # PC4KOHSCE;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), WO # PC4KOHSCE;
CATALOG # PC4KOHSCF, GTIN 885425828084 (ea) 50885425828089 (cs), WO # PC4KOHSCF;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), WO # PC4KOHSCG;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), WO # PC4KOHSCG;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), WO # PC4KOHSCG;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), WO # PC4KOHSCG;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), WO # PC4KOHSCG;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), WO # PC4KOHSCG;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), WO # PC4KOHSCG;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), WO # PC4KOHSCG;
CATALOG # PC4KOHSCG, GTIN 885425844916 (ea) 50885425844911 (cs), WO # PC4KOHSCG;
CATALOG # PC4KOHSC2, GTIN 885425949192 (ea) 50885425949197 (cs), WO # PC4KOHSC2;
CATALOG # PC4KOHSC2, GTIN 885425949192 (ea) 50885425949197 (cs), WO # PC4KOHSC2;
CATALOG # PC4KOHSC2, GTIN 885425949192 (ea) 50885425949197 (cs), WO # PC4KOHSC2;
CATALOG # PC4KOHSC4, GTIN 10887488097046 (ea) 50887488097044 (cs), WO # PC4KOHSC4;
CATALOG # PC4KOHSC4, GTIN 10887488097046 (ea) 50887488097044 (cs), WO # PC4KOHSC4;
CATALOG # PC4KOHSC4, GTIN 10887488097046 (ea) 50887488097044 (cs), WO # PC4KOHSC4;
CATALOG # PC4KOHSC5, GTIN 10887488098807 (ea) 50887488098805 (cs), WO # PC4KOHSC5;
CATALOG # PC4KOHSC5, GTIN 10887488098807 (ea) 50887488098805 (cs), WO # PC4KOHSC5;
CATALOG # PC4KOHSC6, GTIN 10887488123172 (ea) 50887488123170 (cs), WO # PC4KOHSC6;
CATALOG # PC4KOHSC6, GTIN 10887488123172 (ea) 50887488123170 (cs), WO # PC4KOHSC6;
CATALOG # PC4KOHSC7, GTIN 10887488151236 (ea) 50887488151234 (cs), WO # PC4KOHSC7;
CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), WO # PC4KOHSC8;
CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), WO # PC4KOHSC8;
CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), WO # PC4KOHSC8;
CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), WO # PC4KOHSC8;
CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), WO # PC4KOHSC8;
CATALOG # PC4KOHSC9, GTIN 10887488227016 (ea) 50887488227014 (cs), WO # PC4KOHSC9;
CATALOG # PC4KOHS10, GTIN 10887488233680 (ea) 50887488233688 (cs), WO # PC4KOHS10;
CATALOG # PC4KOHS11, GTIN 10887488255316 (ea) 50887488255314 (cs), WO # PC4KOHS11;
CATALOG # PC4KOHS11, GTIN 10887488255316 (ea) 50887488255314 (cs), WO # PC4KOHS11;
CATALOG # PC4KOHS12, GTIN 10887488259666 (ea) 50887488259664 (cs), WO # PC4KOHS12;
CATALOG # PC4KOHS13, GTIN 10887488271569 (ea) 50887488271567 (cs), WO # PC4KOHS13;
CATALOG # PC4KOHS14, GTIN 10887488305028 (ea) 50887488305026 (cs), WO # PC4KOHS14;
CATALOG # PC4KOHS15, GTIN 10887488316734 (ea) 50887488316732 (cs), WO # PC4KOHS15;
CATALOG # PC4KOHS15, GTIN 10887488316734 (ea) 50887488316732 (cs), WO # PC4KOHS15;
CATALOG # PC4KOHS16, GTIN 10887488329437 (ea) 50887488329435 (cs), WO # PC4KOHS16;
CATALOG # PC4KOHS16, GTIN 10887488329437 (ea) 50887488329435 (cs), WO # PC4KOHS16;
CATALOG # BABMH5297E, GTIN 885425102658 (ea) 50885425102653 (cs), WO # BABMH5297E;
CATALOG # BABMH5297E, GTIN 885425102658 (ea) 50885425102653 (cs), WO # BABMH5297E;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # BABMH5297F, GTIN 885425529721 (ea) 50885425529726 (cs), WO # BABMH5297F;
CATALOG # PC4KOHSCA, GTIN 8854251307195 (ea) 58854251307190 (cs), WO # PC4KOHSCA;
CATALOG # PC4KOHSCA, GTIN 8854251307195 (ea) 58854251307190 (cs), WO # PC4KOHSCA;
CATALOG # PC4KOHSCB, GTIN 8854251392788 (ea) 58854251392783 (cs), WO # PC4KOHSCB;
CATALOG # PC4KOHSCB, GTIN 8854251392788 (ea) 58854251392783 (cs), WO # PC4KOHSCB;
CATALOG # PC4KOHSCB, GTIN 8854251392788 (ea) 58854251392783 (cs), WO # PC4KOHSCB;
CATALOG # PC4KOHSCC, GTIN 885425115283 (ea) 50885425115288 (cs), WO # PC4KOHSCC;
CATALOG # PC4KOHSCC, GTIN 885425115283 (ea) 50885425115288 (cs), WO # PC4KOHSCC;
CATALOG # PC4KOHSCC, GTIN 885425115283 (ea) 50885425115288 (cs), WO # PC4KOHSCC;
CATALOG # PC4KOHSCC, GTIN 885425115283 (ea) 50885425115288 (cs), WO # PC4KOHSCC;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), WO # PC4KOHSCD;
CATALOG # PC4KOHSCD, GTIN 885425612744 (ea) 50885425612749 (cs), WO # PC4KOHSCD;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), WO # PC4KOHSCE;
CATALOG # PC4KOHSCE, GTIN 885425754574 (ea) 50885425754579 (cs), WO # PC4KOHSCE;
CATALOG # PC4KOHSC1, GTIN 885425544205 (ea) 50885425544200 (cs), WO # PC4KOHSC1;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP1410346C, GTIN 885425203881 (ea) 50885425203886 (cs), WO # SP1410346C;
CATALOG # SP14103461, GTIN 8854251492020 (ea) 58854251492025 (cs), WO # SP14103461;
CATALOG # SP14103462, GTIN 885425708898 (ea) 50885425708893 (cs), WO # SP14103462;
CATALOG # SP14103462, GTIN 885425708898 (ea) 50885425708893 (cs), WO # SP14103462;
CATALOG # SP14103462, GTIN 885425708898 (ea) 50885425708893 (cs), WO # SP14103462;
CATALOG # SP14103463, GTIN 885425754406 (ea) 50885425754401 (cs), WO # SP14103463;
CATALOG # SP14103464, GTIN 885425764566 (ea) 50885425764561 (cs), WO # SP14103464;
CATALOG # SP14103464, GTIN 885425764566 (ea) 50885425764561 (cs), WO # SP14103464;
CATALOG # SP14103464, GTIN 885425764566 (ea) 50885425764561 (cs), WO # SP14103464;
CATALOG # SP14103464, GTIN 885425764566 (ea) 50885425764561 (cs), WO # SP14103464.
|
| 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 | Notification of performance disclosures of kit component. |
FDA Determined Cause 2 | Other |
| Action | Cardinal Health issued a PRODUCT ADVISORY to its consignees on 10/23/2026 via US mail. The notice explained this was not a recall , but rather an advisory notice to alert the clinicians of this correction. The Cardinal Health Correction notice should be shared with all users. Enclosed in the notice was a copy of the letter from BD. The BD notice explained the issue, clinical impact, and provided Clinical Recommendations for Sets with Updated Performance. The recommendations include using an alternative pump if the BD Alaris Pump with identified infusion sets are not appropriate, and if no alternatives are available to utilized with caution enhanced clinical monitoring, and adherence to previously communicated warnings. Also, implement the Risk Mitigation steps outlined in the v12.3-v12.6 BD Alaris Infusion System User Manual, summarized:
Rate and Bolus Accuracy
1) Avoid hanging the solution container below the BD Alaris Pump Module, or higher than 21 inches above the top of the BD Alaris Pump Module.
Time to Alarm (TTA)
1) When loading the set ensure tubing is directly over the pressure sensors.
2) Ensure all clamps are open; there are no kinks or collapses in the tubing outside of the pump; drops are flowing in the drip chamber. Ensure the vent is open if applicable.
3) Do not use Selectable pressure mode with a setting above 50 mmHg for rates less than 10 mL/h.
Post Occlusion Bolus Volume (POBV)
1) When addressing an occlusion (clearing) ensure that the fluid flow to patient is OFF.
2) Disconnect the tubing to relieve excess pressure through a stopcock if present. Weigh the risks of disconnection with the risks of an unintended bolus.
Discontinuation of Sets and Recommendations:
Immediately discard any sets listed within Attachment C: Discontinued Alaris Pump Sets per your facility's procedures.
a. To receive credit for discarded product, please return the completed Customer Response Form attached to this notice.
If a set is included on Attachment C as disc |
| Quantity in Commerce | 30137 kits |
| Distribution | US: CA, TX, NC |
| Total Product Life Cycle | TPLC Device Report |
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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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