Recall Z-2489-2019 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
| Date | Sep 23, 2019 (initiated May 1, 2019) |
| Status | Terminated |
| Reason | Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site). |
| Root cause | Other |
| Action | Urgent Medical Device - Recall Notification letters dated 4/30/19 were sent to customers. |
| Quantity | 2580 |
| Distribution | Distribution to US state of TX, and Canada. |
| 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 |