Device product
Enteral Infusion Pump
Z-1347-2021
Product summary
- Event
- Event 87281
- Status
- Completed
- Classification
- Class II
- Quantity
- 146,944,334 units
- Official record key
device-enforcement:Z-1347-2021
Official wording
Reason: The potential for air appearing in the enteral feed pumping set tubing during set-up.
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
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
Derived failure modes
-
Unknown
The potential for air appearing in the enteral feed pumping set tubing during set-up.