B.Braun Medical S.A.S. recalls Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4

The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2528-2025
• FDA 510(k) clearance · K130576The device's official FDA premarket clearance record
• FDA 510(k) clearance · K952435The device's official FDA premarket clearance record
• FDA device classification · LJTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5965The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find B.Braun Medical S.A.S.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.