Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version
Summary
The FDA issued a Class II for Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/C by B.Braun Medical S.A.S.. Reason: The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall..
Details
Source
Device Recall
External ID
Z-2528-2025
Action Date
2025-09-17
Status
Ongoing
Category
device
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
Lot/Code Info: Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;
Quantity Affected: 58 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-21
Company
Chasseneuil du Poitou CEDEX, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B.Braun Medical S.A.S.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B.Braun Medical S.A.S. have FDA actions?
This is the only FDA action we have on record for B.Braun Medical S.A.S. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2528-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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