PERFUSOR SPACE — Class II medical device recall Z-0819-2022
Terminated recall by B Braun Medical Inc, reported 2022-03-30, distributed in MA, VT. Units not properly inspected prior to release to the market, may not function as indicated in the product labe
| Recall number | Z-0819-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Breinigsville, PA, United States |
| Recall initiated | 2022-02-07 |
| Classified | 2022-03-22 |
| Reported by FDA | 2022-03-30 |
| Terminated | 2023-12-28 |
| Distributed | MA, VT |
| Quantity | 6 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04046963716745 |
| Serial numbers | 633299, 633307, 633310, 633313, 633315, 633318 |
| Model numbers | 8713030U |
Product
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Reason for recall
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.
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-0819-2022. 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.