FDA Medical Device Recalls (openFDA)
B.Braun Medical S.A.S.: 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
- Recall number
- Z-2528-2025
- Recalling firm
- B.Braun Medical S.A.S.
- 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
- Status
- Open, Classified
- Initiated
- 2025-07-21
- Posted
- 2025-09-05
- Terminated
- not on file
- Reason
- The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 58 units
- Distribution
- US Nationwide distribution in the state of PA.
- Lot, serial or model codes
- Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;
- 510(k) numbers
- ["K130576","K952435"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 3002806713
- Firm city
- Chasseneuil du Poitou CEDEX Cs
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28