Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2436-2024 — 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

U.S. FDA — Device Enforcement · United States · 2024-06-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2436-2024
Date of alert
2024-06-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
B Braun Medical Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
4046963687182
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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