Class II — B Braun Medical Inc
| Recalling firm | B. BRAUN MEDICAL SAS |
|---|---|
| Registered facility | B. BRAUN MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion. |
| Product | PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U |
| Quantity | 6 units |
| Distribution | US Distribution to states of: MA, VT |
| Initiated | 2022-02-07 |
| Classified | 2022-03-22 |
| Terminated | 2023-12-28 |
| Recall number | Z-0819-2022 |
| 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-0819-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89660/
Alerts for B. BRAUN MEDICAL SAS
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.