Recall Z-1347-2021 ยท LZH Pump, Infusion, Enteral
Cardinal Health 200, LLC
Enteral Infusion Pump
| Date | Jan 19, 2021 |
| Status | Completed |
| Reason | The potential for air appearing in the enteral feed pumping set tubing during set-up. |
| Root cause | Process control |
| Action | On 03/01/2021, Cardinal Health issued an Urgent Medical Device Correction notice to customers via letter to the potential of air entering the feed set tubing of enteral fusion pumps with the specified product codes |
| Quantity | 146,944,334 units |
| Distribution | Domestic: All 50 states and DC, Foreign: Argentina, Australia, Brazil, Canada, Chile, Colombia, Japan, Mexico, Netherlands, Panama, Peru, Puerto Rico, Singapore, Switzerland, Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS Tyco Healthcare/Kendall, May 5, 2004 |