FDA Device recall Z-0819-2022
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Nu…
- FDA Device
- Class II
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class II recall of PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Nu… by B Braun Medical, citing 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 r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0819-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-07 |
| Published | 2022-03-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | B Braun Medical |
| Distribution | MA, VT |
Product
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
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.
Identifiers
| code_info | Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0819-2022%22
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