Serious riskFDA DeviceClass I

Cardinal Health Presource kits recalled for performance issues

Cardinal Health is recalling Presource PBDS kits that contain BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100. The infusion sets were recalled for performance issues. About 47,707 kits are affected, sold under 35 catalog numbers, and the FDA has classified this as a Class I recall.

From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls

What to do

  1. Set aside affected kits and stop using them with the BD Alaris Pump Module Model 8100.
  2. Check catalog numbers, GTINs and lot numbers against the affected list in the notice (for example, catalog MA1JV8300C, lot 500060).
  3. The notice doesn't say how to get a replacement or refund; 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,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.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 11 products — see all of them.

Details

Units affected
47707 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, Illinois, United States
Classification
Class I
Recall number
Z-0220-2027

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,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. Kits contain infusion sets which were recalled for performance issues. 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) 508874
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.

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