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Terminated

B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032

FDA Recall Z-2489-2019 · Posted 2019-09-23

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2019-05-01
Date Terminated2020-07-13
Product Quantity2580

Reason for Recall

Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).

Firm Action

Urgent Medical Device - Recall Notification letters dated 4/30/19 were sent to customers.

Root Cause

Other

Distribution Pattern

Distribution to US state of TX, and Canada.

Official Source

View FDA Recall →

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

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