Greiner Bio-One GmbH recalls VACUETTE SAFELINK

The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.

On 11/19/2024, customers and distributors were mailed and emailed recall notices asking them to do the following: 1) Stop using and isolate affected devices. 2) If the product has been further distributed or transferred to another location, notify those locations of the recall, and advise the name/location in the provided space on the attached Product Disposition Site Confirmation. 3) Complete and return the Product Disposition Site Confirmation form via email to recalls.us@gbo.com If you have additional questions, contact the firm's Technical Service Department at 800-515-8112.

• FDA enforcement recordOfficial FDA database entry for Z-0802-2025
• FDA 510(k) clearance · K180545The device's official FDA premarket clearance record
• FDA device classification · FMIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Greiner Bio-One GmbHSearch 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.