Celsite BabyPort Set (B.Braun) – Minor Injury Potential (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
B.Braun Medical S.A.S. Celsa Lg Medical 30 avenue des Temps Modernes; Cs 10031 Chasseneuil du Poitou CEDEX France
Lot Codes / Batch Numbers
Model/Catalog Number: 5433742, Primary-DI 04046963594947, Lot 37041185, Exp 19MAR2030
Products Sold
Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;
B.Braun Medical S.A.S. Celsa Lg Medical 30 avenue des Temps Modernes; Cs 10031 Chasseneuil du Poitou CEDEX France is recalling Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 due to The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Recommended Action
Per FDA guidance
On July 21, 2025 URGENT - FIELD SAFETY NOTICE - PRODUCT RECALL letters were sent to customers. Actions to be taken: Check whether you have the above-mentioned product in stock, and quarantine it. Confirm the receipt of this Field Safety Notice on the enclosed confirmation form. Additionally record on the enclosed confirmation form the received amount of potentially affected products with the above-mentioned batch number(s) as well as the amount used and the amount to be returned. Even if you don't have any inventory, please return the completed and signed confirmation form in a timely manner to the fax number or e-mail address given on the form. Return the quarantined product to the following address with a copy of the enclosed confirmation form. Please retain this Field Safety Notice until you have completed all the above measures. Please make sure that all users of the above-mentioned products in your organization and other concerned persons are informed about this Field Safety Corrective Action. If you have forwarded the products to a third party, please forward a copy of the Field Safety Notice to them or inform the contact person provided. We sincerely apologize for any inconvenience this recall may cause. To compensate for the recalled product(s), a replacement or a credit note. Please contact our dedicated customer service team to arrange for compensation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026