VACUETTE SAFELINK, REF: 450210
This recall is currently active, issued January 3, 2025. It was issued by Greiner Bio-One Gmbh Bad Haller Strase.
- Recall Initiated
- November 19, 2024
- Posted
- January 3, 2025
- Recall Number
- Z-0802-2025
- Quantity
- 188,800 pcs
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of IL, PA.
Lot / Code Info
UDI-DI: 19120049207487, Lot: A240338Q, Expiration Date: 270215
Root Cause
Process control
Action Taken
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.