Serious riskFDA DeviceClass I

Cardinal Health Presource kits recalled for infusion set performance

Cardinal Health Presource PBDS kits labeled KIT, CATH LAB ADMIT (catalog ADMMH2133A) contain BD Alaris Pump Infusion Sets used with the BD Alaris Pump Module Model 8100. The infusion sets were recalled for performance issues. The notice covers 30 kits distributed in the US and Canada and reports no injuries.

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

What to do

  1. Set aside kits from lot 443986 (catalog ADMMH2133A, GTIN 10887488369013) and do not use them.
  2. Contact Cardinal Health about the recall. The notice does not specify a remedy, so ask how to return or replace affected 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: KIT, CATH LAB ADMIT, CATALOG # ADMMH2133A.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 11 products — see all of them.

Details

Units affected
30 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, Illinois, United States
Classification
Class I
Recall number
Z-0214-2027

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, CATH LAB ADMIT, CATALOG # ADMMH2133A. Kits contain infusion sets which were recalled for performance issues. CATALOG # ADMMH2133A, GTIN 10887488369013 (ea) 50887488369011 (cs), LOT # 443986 Distribution: US and Canada Affected quantity: 30 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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