Recall Z-2285-2018 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air
| Date | May 9, 2018 |
| Status | Terminated |
| Reason | There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter. |
| Root cause | Process control |
| Action | B. Braun Medical Inc. sent an Urgent Voluntary Medical Device Recall Notification letter dated May 9, 2018. The letter included the following instructions for customers: 1. Review the Medical 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 and the affected product. Further use of this product should be discontinued immediately and affected product quarantined. 2. If you are a distributor, please immediately forward this recall notification t |
| Quantity | 1,872 |
| Distribution | US Distribution to the states of : CA, IL, and TX., and Internationally to 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 |