—#208603

Product

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K092313
Affected lot / code info: Lot Code: Model No 8713040U; UDI-DI 4046963687182; All Serial Numbers

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

On June 14, 2024, the firm notified customers via URGENT MEDICAL DEVICE FIELD CORRECTION NOTIFICATION letters. Customers were advised to not use the recalled syringes in Perfusor Space Syringe Pumps. All users should be informed of the correction. Customers were provided with an attachment to post in care areas as a reminder to not use the recalled syringes with the specified pumps.

Recalling firm

Firm: B Braun Medical Inc
Address: 200 Boulder Dr, Breinigsville, Pennsylvania 18031-1532

Distribution

Distribution pattern: Domestic distribution nationwide. International distribution to Canada.

Timeline

Recall initiated: 2024-06-14
Posted by FDA: 2024-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208603. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.