Serious riskFDA DeviceClass I

Cardinal Health Presource PBDS kits recalled for performance issues

Cardinal Health is recalling 112 Presource PBDS kits labeled SWAN GANZ, Catalog # PC37SGPHA. The kits contain BD Alaris Pump Infusion Sets used with the BD Alaris Pump Module Model 8100, and those infusion sets were recalled for performance issues. The notice reports no injuries.

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

What to do

  1. Contact Cardinal Health and your care team before using these kits.
  2. Check for Lot # 761270 (GTIN 382602846379 each, 50382602846374 per case).
  3. The notice doesn't say how to get a replacement or refund; contact Cardinal Health.

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: SWAN GANZ, KIT, CATALOG # PC37SGPHA
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 11 products — see all of them.

Details

Units affected
112 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, Illinois, United States
Classification
Class I
Recall number
Z-0219-2027

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: SWAN GANZ, KIT, CATALOG # PC37SGPHA Kits contain infusion sets which were recalled for performance issues. GTIN 382602846379 (ea) 50382602846374 (cs), LOT # 761270 Distribution: US and Canada Affected quantity: 112 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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