FDA recall Z-2437-2024

B Braun Medical Inc · Class II · device

Product

Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 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

Domestic distribution nationwide. International distribution to Canada.

Key facts

Status
Ongoing
Initiation date
2024-06-14
Report date
2024-07-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Breinigsville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2437-2024