Recall Z-0835-2013 ยท FMI Needle, Hypodermic, Single Lumen
Greiner Bio-One North America, Inc.
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
| Date | Feb 15, 2013 (initiated Feb 1, 2013) |
| Status | Terminated |
| Reason | The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece. |
| Root cause | Other |
| Action | Greiner Bio-One sent a notification letter dated January 31, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to stop distributing the affected product, complete the attached Product Disposition form and fax to GBO at 800-726-0052 or email to patech@gbo.com. GBO will contact customers for the return of the affected product after receiving the attached Product Disposition form. Customers were requested to provide the names of customers who may have received the product. For questions call 800-515-81 |
| Quantity | 192,000 pieces (192 cases) |
| Distribution | US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011786 | VACUETTE SAFETY BLOOD COLLECTION SET Greiner Vacuette North America, Inc., Jul 12, 2001 |