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 | There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture. |
| Product | 26-Lead Transfer Set for use with APEX® Compounding System, Product Catalog Number 2112550 |
| Quantity | 12320 |
| Distribution | The products were distributed to the following US states: AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, MN, MO, NC, NJ, NV, OH, PA, TX, and WA. |
| Initiated | 2018-06-04 |
| Classified | 2018-07-03 |
| Terminated | 2020-01-13 |
| Recall number | Z-2343-2018 |
| 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-2343-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80231/
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