Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4 — Class II medical device recall Z-2528-2025
Ongoing recall by B.Braun Medical S.A.S., reported 2025-09-17, distributed nationwide. The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
| Recall number | Z-2528-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B.Braun Medical S.A.S., Chasseneuil du Poitou CEDEX, N/A, France |
| Recall initiated | 2025-07-21 |
| Classified | 2025-09-05 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 58 units |
| UPC / GTIN / UDI-DI | 04046963594947 |
| Lot numbers | 37041185 |
| Model numbers | 5433742 |
| Expiration dates | 2030-03-19 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2528-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.