Recall Z-2528-2025— B.Braun Medical S.A.S.

Name: FDA recall Z-2528-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-21

Class II · Ongoing

Class II FDA medical device recall by B.Braun Medical S.A.S., initiated 2025-07-21. It names 2 FDA 510(k) clearances: K130576, K952435. 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: The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall..

Recalling firm: B.Braun Medical S.A.S.
Classification: Class II
Status: Ongoing
Initiated: 2025-07-21
Firm location: Chasseneuil du Poitou CEDEX, N/A, France

510(k) clearances named in this recall

2 on FDA's record

K130576 — CELSITE IMPLANTABLE ACCESS PORT SYSTEMSB. Braun Interventional Systems, Inc.·cleared 2013-04-02
K952435 — CELSITE PEDIATRIC VENOUS SYSTEMB.Braun Medical, Inc.·cleared 1996-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.