Z-2436-2024 Class II Ongoing
FDA device recall Z-2436-2024 was initiated by B Braun Medical Inc on Jun 14, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 930.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 31, 2024
- Initiation Date
- Jun 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 930
Product Description
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.
Distribution Pattern
Domestic distribution nationwide. International distribution to Canada.
Code Information
Lot Code: Model No 8713040U; UDI-DI 4046963687182; All Serial Numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2436-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026