Cardinal Health Presource PBDS kits recalled for performance issue
Cardinal Health is recalling about 9,571 Presource PBDS kits that contain BD Alaris pump infusion sets for use with the BD Alaris Pump Module Model 8100. The FDA has classified the recall as Class I, and the notice describes a performance problem with a kit component. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls
What to do
- Check the catalog numbers and GTINs in the notice against the kits on hand, and set aside any that match.
- Contact Cardinal Health about the affected kits and what to do with them, because the notice does not state a remedy.
- Contact your care team before changing any infusion setup in use, since the notice does not say to stop using these kits.
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) OPEN HEART A,B,C, KIT CATALOG # PC69HEECD; 2) OPEN HEART A,B,C, KIT CATALOG # PC69HEEC2; 3) OPEN HEART A,B,C,KIT CATALOG # PC69HEEC3; 4) OPEN HEART A,B,C, KIT CATALOG # PC69HEEC4; 5) OPEN HEART A,B,C CATALOG # PC69HEECD; 6) OPEN HEART A,B,C CATALOG # PC69HEECE; 7) KIT, OPEN HEART A,B,C CATALOG # PC69HEECG; 8) OPEN HEART A,B,C CATALOG # PC69HEEC5; 9) OPEN HEART A,B,C CATALOG # PC69HEEC6; 10) OPEN HEART A,B,C CATALOG # PC69HEEC7; 11) OPEN HEART A,B,C CATALOG # PC69HEEC8; 12) KIT, OPEN HEART A,B,C CATALOG # PC69HEEC9; 13) KIT, OPEN HEART A,B,C CATALOG # PC69HEE10; 14) KIT, OPEN HEART A,B,C CATALOG # PC69HEE11; 15) KIT, OPEN HEART A,B,C CATALOG # PC69HEE12; 16) KIT, OPEN HEART A,B,C CATALOG # PC69HEE13; 17) KIT, OPEN HEART A,B,C CATALOG # PV69HEECA; 18) KIT, OPEN HEART A, B, C CATALOG # PV69HEECB; 19) KIT, OPEN HEART A, B, C CATALOG # PV69HEECC; 20) KIT, OPEN HEART A, B, C CATALOG # PV69HEECF; 21) KIT, OPEN HEART A, B, C CATALOG # PV69HEECG; 22) KIT, OPEN HEART A,B,C CATALOG # PV69HEEC1; 23) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC2; 24) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC3; 25) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC4; 26) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC5; 27) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC6; 28) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC7; 29) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC8; 30) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC9; 31) KIT, OPEN HEART A, B, C CATALOG # PV69HEE10; 32) KIT, OPEN HEART A, B, C CATALOG # PV69HEE11; 33) KIT, OPEN HEART A, B, C CATALOG # PV69HEE12; 34) KIT, OPEN HEART A, B, C CATALOG # PV69HEE13; 35) KIT, OPEN HEART A, B, C CATALOG # PV69HEE14; 36) KIT, OPEN HEART A, B, C CATALOG # PV69HEE15; 37) KIT, OPEN HEART A, B, C CATALOG # PV69HEE16; 38) KIT, OPEN HEART A, B, C CATALOG # PV69HEE17; 39) KIT, OPEN HEART A, B, C CATALOG # PV69HEE18; 40) KIT, OPEN HEART A, B, C CATALOG # PV69HEE19; 41) KIT, OPEN HEART A, B, C CATALOG # PV69HEE20; 42) KIT, OPEN HEART A, B, C CATALOG # PV69HEE21; 43) KIT, OPEN HEART A, B, C CATALOG # PV69HEE23; 44) KIT, OPEN HEART A, B, C CATALOG # PV69HEE24; 45) KIT, OPEN HEART A, B, C CATALOG # PV69HEE25; 46) KIT, OPEN HEART A, B, C CATALOG # PV69HEE26; 47) KIT, OPEN HEART A, B, C CATALOG # PV69HEE27; 48) KIT, OPEN HEART A, B, C CATALOG # PV69HEE28; 49) KIT, OPEN HEART A, B, C CATALOG # PV69HEE29; 50) OPEN HEART MC KIT CATALOG # PC46OHASRA; 51) OPEN HEART MC KIT CATALOG # PC46OHASRB; 52) OPEN HEART MC CATALOG # PC46OHASRC; 53) OPEN HEART MC KIT CATALOG # PC46OHASRC; 54) OPEN HEART MC KIT CATALOG # PC46OHASRD; 55) OPEN HEART MC KIT CATALOG # PC46OHASRE; 56) OPEN HEART MC KIT CATALOG # PC46OHASRF; 57) OPEN HEART MC CATALOG # PC46OHASR1; 58) OPEN HEART MC KIT CATALOG # PC46OHASR2; 59) OPEN HEART-DT, SANTA ROSA KIT CATALOG # PC46OHSRA; 60) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRC; 61) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRD; 62) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRG; 63) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRH; 64) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRI; 65) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRJ; 66) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRK; 67) OPEN HEART DT,SANTA ROSA KIT CATALOG # PC46OHSR1; 68) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSR2; 69) OPEN HEART DT,SANTA ROSA KIT CATALOG # PC46OHSR3; 70
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 9571 units
- Illnesses reported
- None reported
- Manufactured in
- 3651 Birchwood Dr, Waukegan, Illinois, United States
- Classification
- Class I
- Recall number
- Z-0329-2027
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) OPEN HEART A,B,C, KIT CATALOG # PC69HEECD; 2) OPEN HEART A,B,C, KIT CATALOG # PC69HEEC2; 3) OPEN HEART A,B,C,KIT CATALOG # PC69HEEC3; 4) OPEN HEART A,B,C, KIT CATALOG # PC69HEEC4; 5) OPEN HEART A,B,C CATALOG # PC69HEECD; 6) OPEN HEART A,B,C CATALOG # PC69HEECE; 7) KIT, OPEN HEART A,B,C CATALOG # PC69HEECG; 8) OPEN HEART A,B,C CATALOG # PC69HEEC5; 9) OPEN HEART A,B,C CATALOG # PC69HEEC6; 10) OPEN HEART A,B,C CATALOG # PC69HEEC7; 11) OPEN HEART A,B,C CATALOG # PC69HEEC8; 12) KIT, OPEN HEART A,B,C CATALOG # PC69HEEC9; 13) KIT, OPEN HEART A,B,C CATALOG # PC69HEE10; 14) KIT, OPEN HEART A,B,C CATALOG # PC69HEE11; 15) KIT, OPEN HEART A,B,C CATALOG # PC69HEE12; 16) KIT, OPEN HEART A,B,C CATALOG # PC69HEE13; 17) KIT, OPEN HEART A,B,C CATALOG # PV69HEECA; 18) KIT, OPEN HEART A, B, C CATALOG # PV69HEECB; 19) KIT, OPEN HEART A, B, C CATALOG # PV69HEECC; 20) KIT, OPEN HEART A, B, C CATALOG # PV69HEECF; 21) KIT, OPEN HEART A, B, C CATALOG # PV69HEECG; 22) KIT, OPEN HEART A,B,C CATALOG # PV69HEEC1; 23) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC2; 24) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC3; 25) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC4; 26) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC5; 27) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC6; 28) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC7; 29) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC8; 30) KIT, OPEN HEART A, B, C CATALOG # PV69HEEC9; 31) KIT, OPEN HEART A, B, C CATALOG # PV69HEE10; 32) KIT, OPEN HEART A, B, C CATALOG # PV69HEE11; 33) KIT, OPEN HEART A, B, C CATALOG # PV69HEE12; 34) KIT, OPEN HEART A, B, C CATALOG # PV69HEE13; 35) KIT, OPEN HEART A, B, C CATALOG # PV69HEE14; 36) KIT, OPEN HEART A, B, C CATALOG # PV69HEE15; 37) KIT, OPEN HEART A, B, C CATALOG # PV69HEE16; 38) KIT, OPEN HEART A, B, C CATALOG # PV69HEE17; 39) KIT, OPEN HEART A, B, C CATALOG # PV69HEE18; 40) KIT, OPEN HEART A, B, C CATALOG # PV69HEE19; 41) KIT, OPEN HEART A, B, C CATALOG # PV69HEE20; 42) KIT, OPEN HEART A, B, C CATALOG # PV69HEE21; 43) KIT, OPEN HEART A, B, C CATALOG # PV69HEE23; 44) KIT, OPEN HEART A, B, C CATALOG # PV69HEE24; 45) KIT, OPEN HEART A, B, C CATALOG # PV69HEE25; 46) KIT, OPEN HEART A, B, C CATALOG # PV69HEE26; 47) KIT, OPEN HEART A, B, C CATALOG # PV69HEE27; 48) KIT, OPEN HEART A, B, C CATALOG # PV69HEE28; 49) KIT, OPEN HEART A, B, C CATALOG # PV69HEE29; 50) OPEN HEART MC KIT CATALOG # PC46OHASRA; 51) OPEN HEART MC KIT CATALOG # PC46OHASRB; 52) OPEN HEART MC CATALOG # PC46OHASRC; 53) OPEN HEART MC KIT CATALOG # PC46OHASRC; 54) OPEN HEART MC KIT CATALOG # PC46OHASRD; 55) OPEN HEART MC KIT CATALOG # PC46OHASRE; 56) OPEN HEART MC KIT CATALOG # PC46OHASRF; 57) OPEN HEART MC CATALOG # PC46OHASR1; 58) OPEN HEART MC KIT CATALOG # PC46OHASR2; 59) OPEN HEART-DT, SANTA ROSA KIT CATALOG # PC46OHSRA; 60) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRC; 61) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRD; 62) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRG; 63) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRH; 64) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRI; 65) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRJ; 66) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSRK; 67) OPEN HEART DT,SANTA ROSA KIT CATALOG # PC46OHSR1; 68) OPEN HEART DT, SANTA ROSA KIT CATALOG # PC46OHSR2; 69) OPEN HEART DT,SANTA ROSA KIT CATALOG # PC46OHSR3; 70 Notification of performance disclosures of kit component. CATALOG # PC69HEECD, GTIN 885425752686 (ea) 50885425752681 (cs), WO # 264455; CATALOG # PC69HEECD, GTIN 885425752686 (ea) 50885425752681 (cs), WO # 267607; CATALOG # PC69HEECD, GTIN 885425752686 (ea) 50885425752681 (cs), WO # 267607; CATALOG # PC69HEEC2, GTIN 887488003736 (ea) 50887488003731 (cs), WO # 276284; CATALOG # PC69HEEC2, GTIN 887488003736 (ea) 50887488003731 (cs), WO # 276284; CATALOG # PC69HEEC3, GTIN 887488038431 (ea) 50887488038436 (cs), WO # 284706; CATALOG # PC69HEEC3, GTIN 887488038431 (ea) 50887488038436 (cs), WO # 284706; CATALOG # PC69HEEC4, GTIN 10887488071039 (ea) 50887488071037 (cs), WO # 292763; CATALOG # PC69HEEC4, GTIN 10887488071039 (ea) 50887488071037 (cs), WO # 292763; CATALOG # PC69HEECD, GTIN 885425752686 (ea) 50885425752681 (cs), WO # 257377; CATALOG # PC69HEECD, GTIN 885425752686 (ea) 50885425752681 (cs), WO # 265386; CATALOG # PC69HEECD, GTIN 885425752686 (ea) 50885425752681 (cs), W
- Hazard
- Notification of performance disclosures of kit component.
2 products in this recall
Cardinal Health Presource kits recalled for performance disclosures
Cardinal Health is recalling 2 Presource PBDS kits that contain BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100. The kits are labeled Open Heart A,B,C (9,571 units) and LDR,MUSC,KIT (30,137 kits), and were sent to CA, TX and NC. The FDA classifies this as Class I, and the notice describes performance disclosures of a kit component; 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) OPEN HEART A,B,C, KI… (this page)Z-0329-2027 · 9571 units
- 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…Z-0330-2027 · 30137 kits
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