FDA-Device2024-07-31Class II
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
B Braun Medical Inc
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
1663
Manufactured in
200 Boulder Dr, Breinigsville, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2435-2024Don't want to check this manually?
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