Recall Z-0802-2025 ยท FMI Needle, Hypodermic, Single Lumen
Greiner Bio-One GmbH
VACUETTE SAFELINK, REF: 450210
| Date | Jan 3, 2025 (initiated Nov 19, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 188,800 pcs |
| Distribution | US Nationwide distribution in the states of IL, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180545 | VACUETTE SAFELINK Holder with male luer lock Greiner Bio-One Na, Inc., May 21, 2018 |