B. Braun Medical, Inc. recalls B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
- Recall date
- May 1, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2489-2019
- FDA classification
- Class I
- Brand / firm
- B. Braun Medical, Inc.
- Sold / distributed
- Distribution to US state of TX, and Canada.
Why it was recalled
Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032
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