FDA Medical devices recall ·
CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model recall
- Recall number
- Z-2528-2025
- Date
- (initiated July 21, 2025)
- Company / brand
- B.Braun Medical S.A.S.
Celsa Lg Medical, Chasseneuil du Poitou CEDEX, N/A, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 58 units
- Hazard tags
- Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;
Distribution
US Nationwide distribution in the state of PA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2528-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.