FDA recall Z-2528-2025

B.Braun Medical S.A.S. · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the state of PA.

Key facts

Status: Ongoing
Initiation date: 2025-07-21
Report date: 2025-09-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chasseneuil du Poitou CEDEX, N/A, France

Primary source

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