Z-1347-2021 Class II
FDA device recall Z-1347-2021 was initiated by Cardinal Health 200, LLC on January 19, 2021 and is designated Class II. Reason for recall: The potential for air appearing in the enteral feed pumping set tubing during set-up. Affected quantity: 146,944,334 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- January 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146,944,334 units
Product Description
Enteral Infusion Pump
Reason for Recall
The potential for air appearing in the enteral feed pumping set tubing during set-up.
Distribution Pattern
Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey
Code Information
Catalog Number: 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150