CELSITE recallZ-2528-2025 · B.Braun Medical S.A.S. · initiated Jul 21, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B.Braun Medical S.A.S. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2528-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 21, 2025
- Posted by the FDA
- Sep 5, 2025
- Recalling firm
- B.Braun Medical S.A.S.
- Quantity
- 58 units
- Product code
- LJT
- FDA submissions
- K130576, K952435
- Distribution
- US Nationwide distribution in the state of PA.
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
Code information (models, lots, serial numbers)
Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CELSITE 5433742B Braun Interventional Systems, Inc · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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