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Open, Classified

Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A

FDA Recall Z-2437-2024 · Posted 2024-07-25

Recalling FirmB Braun Medical Inc
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2024-06-14
Product Quantity4519

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

Domestic distribution nationwide. International distribution to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191910SpaceStation MRIB. Braun Melsugen AG · 2020-03-12K172831Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc. · 2018-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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