Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product… — Class II medical device recall Z-1907-2016
Terminated recall by B. Braun Medical, Inc., reported 2016-06-08, distributed nationwide. BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. T
| Recall number | Z-1907-2016 |
|---|---|
| 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 | 2016-04-14 |
| Classified | 2016-06-02 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 11,000 units |
| Reason classes | labeling |
| Serial numbers | 61181826, 61187901, 61200666, 61221679, 61230098, 61247686, 61250908, 61259709, 61266076, 61277092, 61282829, 61315864, 61316886, 61318424, 61321589, 61325854, 61342856 |
| Model numbers | 412023, 412027 |
Product
Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
Reason for recall
BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.
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-1907-2016. 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.