# FDA recall Z-2528-2025

> **B.Braun Medical S.A.S.** · Class II · device recall initiated 2025-07-21.

## 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

- **Recall number:** Z-2528-2025
- **Recalling firm:** B.Braun Medical S.A.S.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2528-2025. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2528-2025. Source: US FDA. Licensed CC0.

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