Z-2528-2025Class II

Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software...

Name: Z-2528-2025 Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software...
Creator: B.Braun Medical S.A.S.
Published: 2025-07-21
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2025-07-21 / Open, Classified

FDA source

B.Braun Medical S.A.S. began a recall of Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE... on 2025-07-21. FDA classified it as Class II and gives the reason as "The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2528-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-21
Posted: 2025-09-05
Recalling firm: B Braun Medical Inc
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
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
FDA 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 in commerce: 58 units
Distribution: US Nationwide distribution in the state of PA.
Product codes and lots: Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2528-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2528-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05

Product code LJT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)