Serious riskFDA DeviceClass I

Cardinal Health Presource kits recalled for infusion set issues

Cardinal Health Presource PBDS emergency basket kits contain BD Alaris infusion sets that were recalled for performance issues. The notice does not describe the specific performance problem, and no injuries have been reported. The recall covers 48 kits in the US and Canada.

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

What to do

  1. Set aside any kits from Lot # 964798 (GTIN 10195594772482 per kit, 50195594772480 per case) and do not use them.
  2. The notice does not specify a remedy; contact Cardinal Health for instructions on return or replacement.

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: KIT EMERGENCY BASKET GENERAL, CATALOG # RES307732A
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 11 products — see all of them.

Details

Units affected
48 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, Illinois, United States
Classification
Class I
Recall number
Z-0222-2027

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: KIT EMERGENCY BASKET GENERAL, CATALOG # RES307732A Kits contain infusion sets which were recalled for performance issues. GTIN 10195594772482 (ea) 50195594772480 (cs), Lot # 964798 Distribution: US and Canada Affected quantity: 48 kits
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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