Recall Z-2137-2021 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
| Date | Jun 25, 2021 |
| Status | Terminated |
| Reason | There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump. |
| Root cause | Process control |
| Action | Urgent Medical Device Recall Notification letters dated 6/25/21 were sent to customers. Actions Required By BBMI Customer/User: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the customer level. 2. Determine your current inventory of the affected lot within your facility, cease use and quarantine product subject |
| Quantity | 36,144 units |
| Distribution | Affected products were distributed to the following US states: CA, MI, OR, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142036 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS B.Braun Medical, Inc., Aug 25, 2014 |