Medical device recalls Moderate risk

B.Braun Medical S.A.S. recalls Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version:…

Recall date
July 21, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2528-2025
FDA classification
Class II
Brand / firm
B.Braun Medical S.A.S.
Sold / distributed
US Nationwide distribution in the state of PA.

Why it was recalled

The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A

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