FDAFDA · Food and drugs·Recall number 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
Published July 31, 2024 · Recall initiated: June 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B Braun Medical Inc
- Distributor
- Domestic distribution nationwide. International distribution to Canada.
- Lot
- Lot Code: Model No 8713040U; UDI-DI 4046963687182; All Serial Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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