FDA-Device2025-09-17Class II

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

B.Braun Medical S.A.S.
Hazard

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

Sold states
US Nationwide distribution in the state of PA.
Affected count
58 units
Manufactured in
Celsa Lg Medical, 30 avenue des Temps Modernes; Cs 10031, Chasseneuil du Poitou CEDEX, N/A, France
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2528-2025

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