Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT… — Class II medical device recall Z-2436-2024
Ongoing recall by B Braun Medical Inc, reported 2024-07-31, distributed nationwide. Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for us
| Recall number | Z-2436-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Breinigsville, PA, United States |
| Recall initiated | 2024-06-14 |
| Classified | 2024-07-25 |
| Reported by FDA | 2024-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 930 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04046963687182 |
| Model numbers | 8713040U |
Product
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
Reason for recall
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
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-2436-2024. 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.