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Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 54...

FDA Recall #Z-2528-2025 — Class II — July 21, 2025

Recall #Z-2528-2025 Date: July 21, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

B.Braun Medical S.A.S. — Chasseneuil du Poitou CEDEX, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

58 units

Distribution

US Nationwide distribution in the state of PA.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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