Z-2435-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2024
- Initiation Date
- June 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1663
Product Description
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, 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 Pattern
Domestic distribution nationwide. International distribution to Canada.
Code Information
Lot Code: Model No 8713080U; UDI-DI 4046963915308; All Serial Numbers