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U.S. Department of Health and Human Services

Class 2 Device Recall CELSITE

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 Class 2 Device Recall CELSITEsee related information
Date Initiated by FirmJuly 21, 2025
Date PostedSeptember 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2528-2025
Recall Event ID 97407
510(K)NumberK130576 K952435 
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
ProductBrand 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 Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;
Recalling Firm/
Manufacturer		 B.Braun Medical S.A.S.
Celsa Lg Medical
30 avenue des Temps Modernes; Cs 10031
Chasseneuil du Poitou CEDEX France
For Additional Information ContactAllison Longenhagen
001-484-2408373
Manufacturer Reason
for Recall		The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 Commerce58 units
DistributionUS Nationwide distribution in the state of PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LJT
510(K)s with Product Code = LJT
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