Outlook Safety Infusion System Burette Set — Class II medical device recall Z-2166-2013
Terminated recall by B. Braun Medical, Inc., reported 2013-09-18, distributed in FL, NJ, NY, TX. Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375
| Recall number | Z-2166-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2013-08-05 |
| Classified | 2013-09-06 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2014-09-03 |
| Distributed | FL, NJ, NY, TX |
| Quantity | 900 |
| Lot numbers | 0061317318 |
| Expiration dates | 2016-04-30 |
Product
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2166-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.