Class II — B. Braun Medical, Inc.
| Recalling firm | B. BRAUN MEDICAL INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Complaints were received reporting leakage on certain lots of SAFSITE® Injection Sites and IV Sets manufactured with SAFSITE® Injection Sites.The SAFSITE® Injection Site is intended to provide needle free access on IV and Extension Sets. |
| Product | SAFSITE® Injection Sites and IV Sets manufactured with SAFSITE® Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. |
| Quantity | 2,357,944 |
| Distribution | Nationwide Distribution. |
| Initiated | 2014-01-08 |
| Classified | 2014-02-18 |
| Terminated | 2014-11-03 |
| Recall number | Z-0987-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — B. Braun Medical, Inc. (Z-0987-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67236/
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