Serious riskFDA DeviceClass I

Cardinal Health anesthesia kits recalled for infusion set performance

Cardinal Health is recalling Presource PBDS anesthesia and open heart anesthesia kits that contain BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100. The infusion sets in these kits were recalled for performance issues. About 12,358 kits are affected, and no injuries have been reported.

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

What to do

  1. Set aside affected kits and do not use them.
  2. Check each kit's catalog number and lot number against the lists in the notice.
  3. Contact Cardinal Health for next steps. The notice does not specify a remedy, such as a replacement or refund.

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, ANESTHESIA, CATALOG # IVSVM41612; 2) KIT, ANESTHESIA, CATALOG # IVSVM41611; 3) KIT, ANESTHESIA, CATALOG # IVSVM41610; 4) KIT, ANESTHESIA, CATALOG # IVSVM41669; 5) KIT, ANESTHESIA, CATALOG # IVSVM41668; 6) KIT, ANESTHESIA, CATALOG # IVSVM41667; 7) KIT, ANESTHESIA, CATALOG # IVSVM4166C; 8) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS16; 9) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS15; 10) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS14; 11) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS13; 12) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS12; 13) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS11; 14) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS10; 15) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC9; 16) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC8; 17) KIT, ANESTHESIA, CATALOG # IVSVM4166B; 18) KIT, ANESTHESIA, CATALOG # IVSVM41666; 19) OPEN HEART ANESTHESIA, , CATALOG # PC4KOHSC7; 20) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC6; 21) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC5; 22) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC4; 23) OPEN HEART ANESTHESIA KIT, CATALOG # PC4KOHSCB; 24) OPEN HEART ANESTHESIA KIT, CATALOG # PC4KOHSCA; 25) KIT,ANESTHESIA, CATALOG # PZVMANMOP; 26) KIT, ANESTHESIA, CATALOG # IVSVM41665; 27) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC2; 28) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCG; 29) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCF; 30) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE; 31) OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE; 32) KIT, ANESTHESIA , CATALOG # IVSVM4166A; 33) KIT,ANESTHESIA , CATALOG # PZVMANMO3; 34) KIT,OPEN HEART ANESTHESIA , CATALOG # PC4KOHSCD; 35) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCD; 36) KIT,ANESTHESIA , CATALOG # PZVMANMOQ; 37) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCC.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 11 products — see all of them.

Details

Units affected
12358 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, Illinois, United States
Classification
Class I
Recall number
Z-0212-2027

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, ANESTHESIA, CATALOG # IVSVM41612; 2) KIT, ANESTHESIA, CATALOG # IVSVM41611; 3) KIT, ANESTHESIA, CATALOG # IVSVM41610; 4) KIT, ANESTHESIA, CATALOG # IVSVM41669; 5) KIT, ANESTHESIA, CATALOG # IVSVM41668; 6) KIT, ANESTHESIA, CATALOG # IVSVM41667; 7) KIT, ANESTHESIA, CATALOG # IVSVM4166C; 8) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS16; 9) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS15; 10) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS14; 11) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS13; 12) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS12; 13) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS11; 14) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS10; 15) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC9; 16) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC8; 17) KIT, ANESTHESIA, CATALOG # IVSVM4166B; 18) KIT, ANESTHESIA, CATALOG # IVSVM41666; 19) OPEN HEART ANESTHESIA, , CATALOG # PC4KOHSC7; 20) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC6; 21) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC5; 22) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC4; 23) OPEN HEART ANESTHESIA KIT, CATALOG # PC4KOHSCB; 24) OPEN HEART ANESTHESIA KIT, CATALOG # PC4KOHSCA; 25) KIT,ANESTHESIA, CATALOG # PZVMANMOP; 26) KIT, ANESTHESIA, CATALOG # IVSVM41665; 27) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC2; 28) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCG; 29) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCF; 30) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE; 31) OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE; 32) KIT, ANESTHESIA , CATALOG # IVSVM4166A; 33) KIT,ANESTHESIA , CATALOG # PZVMANMO3; 34) KIT,OPEN HEART ANESTHESIA , CATALOG # PC4KOHSCD; 35) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCD; 36) KIT,ANESTHESIA , CATALOG # PZVMANMOQ; 37) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCC. Kits contain infusion sets which were recalled for performance issues. CATALOG # IVSVM41612, GTIN 10888439827576 (ea) 50888439827574 (cs), LOT #433785; CATALOG # IVSVM41612, GTIN 10888439827576 (ea) 50888439827574 (cs), LOT #433785; CATALOG # IVSVM41612, GTIN 10888439827576 (ea) 50888439827574 (cs), LOT #433785; CATALOG # IVSVM41611, GTIN 10888439795370 (ea) 50888439795378 (cs), LOT #408485; CATALOG # IVSVM41610, GTIN 10888439725094 (ea) 50888439725092 (cs), LOT #381796; CATALOG # IVSVM41610, GTIN 10888439725094 (ea) 50888439725092 (cs), LOT #381796; CATALOG # IVSVM41610, GTIN 10888439725094 (ea) 50888439725092 (cs), LOT #381796; CATALOG # IVSVM41669, GTIN 10888439616132 (ea) 50888439616130 (cs), LOT #326127; CATALOG # IVSVM41668, GTIN 10888439360172 (ea) 50888439360170 (cs), LOT #166245; CATALOG # IVSVM41668, GTIN 10888439360172 (ea) 50888439360170 (cs), LOT #166245; CATALOG # IVSVM41668, GTIN 10888439360172 (ea) 50888439360170 (cs), LOT #166245; CATALOG # IVSVM41667, GTIN 10888439315936 (ea) 50888439315934 (cs), LOT #149124; CATALOG # IVSVM41667, GTIN 10888439315936 (ea) 50888439315934 (cs), LOT #149124; CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #105414; CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #191135; CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #191135; CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #227900; CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #227900; CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #254339; CATALOG # IVSVM4166C, GTIN 10888439183559 (ea) 50888439183557 (cs), LOT #296385; CATALOG # PC4KOHS16, GTIN 10887488329437 (ea) 50887488329435 (cs), LOT #397529; CATALOG # PC4KOHS15, GTIN 10887488316734 (ea) 50887488316732 (cs), LOT #386921; CATALOG # PC4KOHS14, GTIN 10887488305028 (ea) 50887488305026 (cs), LOT #376919; CATALOG # PC4KOHS13, GTIN 10887488271569 (ea) 50887488271567 (cs), LOT #356104; CATALOG # PC4KOHS13, GTIN 10887488271569 (ea) 50887488271567 (cs), LOT #356104; CATALOG # PC4KOHS12, GTIN 10887488259666 (ea) 50887488259664 (cs), LOT #348361; CATALOG # PC4KOHS11, GTIN 10887488255316 (ea) 50887488255314 (cs), LOT #343851; CATALOG # PC4KOHS10, GTIN 10887488233680 (ea) 50887488233688 (cs), LOT #328666; CATALOG # PC4KOHSC9, GTIN 10887488227016 (ea) 50887488227014 (cs), LOT #325958; CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), LOT #300901; CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), LOT #300901; CATALOG # PC4KOHSC8, GTIN 10887488193021 (ea) 50887488193029 (cs), LOT #300901; CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #295338; CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #295338; CATALOG # IVSVM4166B, GTIN 10887488174174 (ea) 50887488174172 (cs), LOT #295338; CATALO
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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