Recall Z-2166-2013 ยท FRN Pump, Infusion
B. Braun Medical, Inc.
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
| Date | Sep 6, 2013 (initiated Aug 5, 2013) |
| Status | Terminated |
| Reason | Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down. |
| Root cause | Process control |
| Action | On August 4, 2013, a letter was sent to direct accounts asking them to check their inventory for the affected product. These customers were also instructed to notify their customers if the product was further distributed and to return all affected product and/or the product removal acknowledgement form. |
| Quantity | 900 |
| Distribution | Distributed in the states of FL, NY, NJ, and TX. |
| FDA record | Open on fda.gov |