Cardinal Health Presource kits recalled for infusion set performance issues
Cardinal Health Presource PBDS kits contain BD Alaris Pump Infusion Sets, which were recalled for performance issues. The kits are used with the BD Alaris Pump Module Model 8100. The notice covers 21,429 units across many catalog numbers and lots.
From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls
What to do
- Set aside affected kits and do not use them.
- Check catalog and lot numbers against the notice's full list, for example catalog PCOCCG3A12, lot 343414.
- The notice does not specify a remedy; contact Cardinal Health for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT, CABG, , CATALOG # PCOCCG3A12; 2) KIT, CABG, , CATALOG # PCOCCG3A11; 3) KIT, TAVR , CATALOG # PCOCTVWP6; 4) KIT, TAVR , CATALOG # PCOCTVWP5; 5) KIT, VALVE, , CATALOG # PCOC49365; 6) KIT, VALVE, , CATALOG # PCOC49364; 7) KIT, VALVE, , CATALOG # PCOC49363; 8) KIT, CABG, , CATALOG # PCOCCG3A10; 9) KIT, VALVE, , CATALOG # PCOC4936B; 10) KIT, CABG, , CATALOG # PCOCCG3A9; 11) KIT, VALVE, , CATALOG # PCOC49362; 12) KIT, CABG, , CATALOG # PCOCCG3A8; 13) KIT, VALVE, , CATALOG # PCOC49361; 14) KIT, CABG, , CATALOG # PCOCCG3A7; 15) KIT, CABG, , CATALOG # PCOCCG3AM; 16) KIT, TAVR , CATALOG # PCOCTVWPM; 17) KIT,VALVE, , CATALOG # PCOCVR3671; 18) KIT,CABG, , CATALOG # PCOCCG3A6; 19) KIT,TAVR , CATALOG # PCOCTVWPK; 20) KIT,VALVE, , CATALOG # PCOCVR3670; 21) KIT,CABG, , CATALOG # PCOCCG3A5; 22) KIT,CABG, , CATALOG # PCOCCG3AJ; 23) CABG,, KIT , CATALOG # PCOCCG3A4; 24) KIT,TAVR , CATALOG # PCOCTVWP4; 25) TAVR ,KIT , CATALOG # PCOCTVWP3; 26) CABG,,KIT , CATALOG # PCOCCG3A3; 27) VALVE,,KIT , CATALOG # PCOCVR369; 28) CABG,,KIT , CATALOG # PCOCCG3A2; 29) CABG,,KIT , CATALOG # PCOCCG3AI; 30) TAVR ,KIT , CATALOG # PCOCTVWPJ; 31) KIT,VALVE, , CATALOG # PCOCVR36X; 32) VALVE,, KIT , CATALOG # PCOCVR36X; 33) VALVE,,KIT , CATALOG # PCOCVR36X; 34) CABG,,KIT , CATALOG # PCOCCG3AH; 35) TAVR ,KIT , CATALOG # PCOCTVWPH; 36) CABG,,KIT , CATALOG # PCOCCG3AE; 37) VALVE,,KIT , CATALOG # PCOCVR368; 38) VALVE,,KIT , CATALOG # PCOCVR36U; 39) CABG,,KIT , CATALOG # PCOCCG3AD; 40) VALVE,,KIT , CATALOG # PCOCVR367; 41) CABG,,KIT , CATALOG # PCOCCG3AC; 42) TAVR ,KIT , CATALOG # PCOCTVWPG; 43) CABG,,KIT , CATALOG # PCOCCG3AB; 44) TAVR , KIT , CATALOG # PCOCTVWPF; 45) TAVR ,KIT , CATALOG # PCOCTVWPF; 46) CABG,,KIT , CATALOG # PCOCCG3A1; 47) VALVE,,KIT , CATALOG # PCOCVR36S; 48) CABG,,KIT , CATALOG # PCOCCG3AA; 49) TAVR , KIT , CATALOG # PCOCTVWPE; 50) TAVR , KIT , CATALOG # PCOCTVWPD; 51) TAVR , KIT , CATALOG # PCOCTVWP2; 52) TAVR , KIT , CATALOG # PCOCTVWPC; 53) CABG,, KIT , CATALOG # PCOCCG36Z; 54) CABG,,KIT , CATALOG # PCOCCG36Z; 55) KIT,CABG, , CATALOG # PCOCCG36Z; 56) KIT,CABG, , CATALOG # PCOCCG36Y; 57) KIT, BAL OPEN HEART , CATALOG # PVCGOHB28; 58) KIT, BAL OPEN HEART , CATALOG # PVCGOHB27; 59) KIT, BAL OPEN HEART , CATALOG # PVCGOHB26; 60) KIT, BAL OPEN HEART , CATALOG # PVCGOHB24; 61) KIT, BAL OPEN HEART , CATALOG # PVCGOHB23; 62) KIT, BAL OPEN HEART , CATALOG # PVCGOHB22; 63) KIT, BAL OPEN HEART , CATALOG # PVCGOHB21; 64) KIT, BAL OPEN HEART , CATALOG # PVCGOHB20; 65) KIT, BAL OPEN HEART , CATALOG # PVCGOHB19; 66) KIT, BAL OPEN HEART , CATALOG # PVCGOHB18; 67) KIT, BAL OPEN HEART , CATALOG # PVCGOHB17; 68) KIT, BAL OPEN HEART , CATALOG # PVCGOHB16; 69) KIT, BAL OPEN HEART , CATALOG # PVCGOHB15; 70) KIT, BAL OPEN HEART , CATALOG # PVCGOHB14; 71) KIT, BAL OPEN HEART , CATALOG # PVCGOHB13; 72) VALVE,,KIT , CATALOG # PCOCVR365; 73) CABG, KIT , CATALOG # PCOCCG366; 74) CV A B C,2,KIT, CATALOG # UCV63CVM11; 75) CV A B C,2,KIT , CATALOG # UCV63CVM10; 76) VA
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 11 products — see all of them.
Details
- Units affected
- 21429 units
- Illnesses reported
- None reported
- Manufactured in
- 3651 Birchwood Dr, Waukegan, Illinois, United States
- Classification
- Class I
- Recall number
- Z-0215-2027
In the FDA's words
- Description
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT, CABG, , CATALOG # PCOCCG3A12; 2) KIT, CABG, , CATALOG # PCOCCG3A11; 3) KIT, TAVR , CATALOG # PCOCTVWP6; 4) KIT, TAVR , CATALOG # PCOCTVWP5; 5) KIT, VALVE, , CATALOG # PCOC49365; 6) KIT, VALVE, , CATALOG # PCOC49364; 7) KIT, VALVE, , CATALOG # PCOC49363; 8) KIT, CABG, , CATALOG # PCOCCG3A10; 9) KIT, VALVE, , CATALOG # PCOC4936B; 10) KIT, CABG, , CATALOG # PCOCCG3A9; 11) KIT, VALVE, , CATALOG # PCOC49362; 12) KIT, CABG, , CATALOG # PCOCCG3A8; 13) KIT, VALVE, , CATALOG # PCOC49361; 14) KIT, CABG, , CATALOG # PCOCCG3A7; 15) KIT, CABG, , CATALOG # PCOCCG3AM; 16) KIT, TAVR , CATALOG # PCOCTVWPM; 17) KIT,VALVE, , CATALOG # PCOCVR3671; 18) KIT,CABG, , CATALOG # PCOCCG3A6; 19) KIT,TAVR , CATALOG # PCOCTVWPK; 20) KIT,VALVE, , CATALOG # PCOCVR3670; 21) KIT,CABG, , CATALOG # PCOCCG3A5; 22) KIT,CABG, , CATALOG # PCOCCG3AJ; 23) CABG,, KIT , CATALOG # PCOCCG3A4; 24) KIT,TAVR , CATALOG # PCOCTVWP4; 25) TAVR ,KIT , CATALOG # PCOCTVWP3; 26) CABG,,KIT , CATALOG # PCOCCG3A3; 27) VALVE,,KIT , CATALOG # PCOCVR369; 28) CABG,,KIT , CATALOG # PCOCCG3A2; 29) CABG,,KIT , CATALOG # PCOCCG3AI; 30) TAVR ,KIT , CATALOG # PCOCTVWPJ; 31) KIT,VALVE, , CATALOG # PCOCVR36X; 32) VALVE,, KIT , CATALOG # PCOCVR36X; 33) VALVE,,KIT , CATALOG # PCOCVR36X; 34) CABG,,KIT , CATALOG # PCOCCG3AH; 35) TAVR ,KIT , CATALOG # PCOCTVWPH; 36) CABG,,KIT , CATALOG # PCOCCG3AE; 37) VALVE,,KIT , CATALOG # PCOCVR368; 38) VALVE,,KIT , CATALOG # PCOCVR36U; 39) CABG,,KIT , CATALOG # PCOCCG3AD; 40) VALVE,,KIT , CATALOG # PCOCVR367; 41) CABG,,KIT , CATALOG # PCOCCG3AC; 42) TAVR ,KIT , CATALOG # PCOCTVWPG; 43) CABG,,KIT , CATALOG # PCOCCG3AB; 44) TAVR , KIT , CATALOG # PCOCTVWPF; 45) TAVR ,KIT , CATALOG # PCOCTVWPF; 46) CABG,,KIT , CATALOG # PCOCCG3A1; 47) VALVE,,KIT , CATALOG # PCOCVR36S; 48) CABG,,KIT , CATALOG # PCOCCG3AA; 49) TAVR , KIT , CATALOG # PCOCTVWPE; 50) TAVR , KIT , CATALOG # PCOCTVWPD; 51) TAVR , KIT , CATALOG # PCOCTVWP2; 52) TAVR , KIT , CATALOG # PCOCTVWPC; 53) CABG,, KIT , CATALOG # PCOCCG36Z; 54) CABG,,KIT , CATALOG # PCOCCG36Z; 55) KIT,CABG, , CATALOG # PCOCCG36Z; 56) KIT,CABG, , CATALOG # PCOCCG36Y; 57) KIT, BAL OPEN HEART , CATALOG # PVCGOHB28; 58) KIT, BAL OPEN HEART , CATALOG # PVCGOHB27; 59) KIT, BAL OPEN HEART , CATALOG # PVCGOHB26; 60) KIT, BAL OPEN HEART , CATALOG # PVCGOHB24; 61) KIT, BAL OPEN HEART , CATALOG # PVCGOHB23; 62) KIT, BAL OPEN HEART , CATALOG # PVCGOHB22; 63) KIT, BAL OPEN HEART , CATALOG # PVCGOHB21; 64) KIT, BAL OPEN HEART , CATALOG # PVCGOHB20; 65) KIT, BAL OPEN HEART , CATALOG # PVCGOHB19; 66) KIT, BAL OPEN HEART , CATALOG # PVCGOHB18; 67) KIT, BAL OPEN HEART , CATALOG # PVCGOHB17; 68) KIT, BAL OPEN HEART , CATALOG # PVCGOHB16; 69) KIT, BAL OPEN HEART , CATALOG # PVCGOHB15; 70) KIT, BAL OPEN HEART , CATALOG # PVCGOHB14; 71) KIT, BAL OPEN HEART , CATALOG # PVCGOHB13; 72) VALVE,,KIT , CATALOG # PCOCVR365; 73) CABG, KIT , CATALOG # PCOCCG366; 74) CV A B C,2,KIT, CATALOG # UCV63CVM11; 75) CV A B C,2,KIT , CATALOG # UCV63CVM10; 76) VA Kits contain infusion sets which were recalled for performance issues. CATALOG # PCOCCG3A12, GTIN 10888439642704 (ea) 50888439642702 (cs), LOT #343414; CATALOG # PCOCCG3A12, GTIN 10888439642704 (ea) 50888439642702 (cs), LOT #343414; CATALOG # PCOCCG3A12, GTIN 10888439642704 (ea) 50888439642702 (cs), LOT #343414; CATALOG # PCOCCG3A12, GTIN 10888439642704 (ea) 50888439642702 (cs), LOT #343414; CATALOG # PCOCCG3A12, GTIN 10888439642704 (ea) 50888439642702 (cs), LOT #343414; CATALOG # PCOCCG3A12, GTIN 10888439642704 (ea) 50888439642702 (cs), LOT #343414; CATALOG # PCOCCG3A12, GTIN 10888439642704 (ea) 50888439642702 (cs), LOT #343414; CATALOG # PCOCCG3A11, GTIN 10888439630251 (ea) 50888439630259 (cs), LOT #330531; CATALOG # PCOCCG3A11, GTIN 10888439630251 (ea) 50888439630259 (cs), LOT #330531; CATALOG # PCOCTVWP6, GTIN 10888439563825 (ea) 50888439563823 (cs), LOT #282909; CATALOG # PCOCTVWP5, GTIN 10888439522723 (ea) 50888439522721 (cs), LOT #540243; CATALOG # PCOC49365, GTIN
- Hazard
- Kits contain infusion sets which were recalled for performance issues.
11 products in this recall
Cardinal Health Presource kits recalled for infusion set issues
FDA classified this as a Class I recall of 11 Cardinal Health Presource PBDS kits, distributed in the US and Canada. Each kit contains BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100, and the infusion sets were recalled for performance issues. The kits are labeled with names such as anesthesia, cath lab, C-section, labor, and emergency kits. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT, ANESTHESIA, CA…Z-0212-2027 · 12358 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) STR CATH ANGIO PEDI…Z-0213-2027 · 3981 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT, CATH LAB ADMIT, CA…Z-0214-2027 · 30 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT, CABG,… (this page)Z-0215-2027 · 21429 units
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT,C SECTION ADMI…Z-0216-2027 · 3702 units
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT, ANTEPARTUM IV…Z-0217-2027 · 415636 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) IV START LD KIT…Z-0218-2027 · 221554 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: SWAN GANZ, KIT, CATALOG…Z-0219-2027 · 112 kits
- 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,…Z-0220-2027 · 47707 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) C SECTION, ADM, KI…Z-0221-2027 · 15247 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT EMERGENCY BASKET GE…Z-0222-2027 · 48 kits
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