Skip to content
Recall Observatory FDA recall evidence

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

Z-2528-2025

July 21, 2025

Class II

Product summary

Firm
B.Braun Medical S.A.S.
Event
Event 97407
Status
Ongoing
Classification
Class II
Quantity
58 units
Official record key
device-enforcement:Z-2528-2025

Official wording

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

Code information: Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;

Distribution pattern: US Nationwide distribution in the state of PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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