Infusomat Space Volumetric Pump Administration Set — Class II medical device recall Z-2137-2021
Terminated recall by B. Braun Medical, Inc., reported 2021-08-04, distributed in CA, MI, OR, UT. There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unin
| Recall number | Z-2137-2021 |
|---|---|
| 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 | 2021-06-25 |
| Classified | 2021-07-23 |
| Reported by FDA | 2021-08-04 |
| Terminated | 2023-10-16 |
| Distributed | CA, MI, OR, UT |
| Quantity | 36,144 units |
| Lot numbers | 0061761278 |
Product
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Reason for recall
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
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-2137-2021. 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.