FDA-Device2024-07-31Class II
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
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.
Sold states
Domestic distribution nationwide. International distribution to Canada.
Affected count
930
Manufactured in
200 Boulder Dr, Breinigsville, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2436-2024More B Braun Medical Inc recalls
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- FDA-Device2026-04-22B. Braun STREAMLINE BLOODLINE SET recalled for air bubble risk in hemodialysis
- FDA-Device2026-04-22B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- FDA-Device2026-04-22B Braun hemodialysis bloodlines recalled for potential air bubble accumulation in arterial line
- FDA-Device2026-04-22B. Braun hemodialysis bloodlines recalled for potential air bubble accumulation
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