FDA Device recall Z-2166-2013
Outlook Safety Infusion System Burette Set
- FDA Device
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of Outlook Safety Infusion System Burette Set by B Braun Medical, citing 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 inje….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2166-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-05 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | B Braun Medical |
| Distribution | FL, NJ, NY, TX |
Product
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
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.
Identifiers
| code_info | Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2013%22
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