Recall Z-2055-2019 ยท FRN Pump, Infusion
InfuTronix LLC
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
| Date | Jul 23, 2019 (initiated May 28, 2019) |
| Status | Terminated |
| Reason | Potential for tube leakage |
| Root cause | Employee error |
| Action | On May 28, 2019 InfuTronix LLC issued Voluntary Recall notices to their customer via email. On June 10, 2019, InfuTronix LLC issued a second notice to customers via email dated June 4, 2019 which provides more information on the reason for recall. On August 6th, 2019, InfuTronix LLC issued a third Urgent Medical Device Recall notice to customers advising them of an additional lot. Customers are advised to take the following actions: 1) Inspect stock and remove all products listd on the notice. 2) Immediately return them to InfuTronix LLC for replacement. 3) Customers may call the telepho |
| Quantity | 10,800 units |
| Distribution | US distribution in the state of MA |
| FDA record | Open on fda.gov |