Recall Z-1116-2020 ยท CCW Laryngoscope, Rigid
TELEFLEX MEDICAL INC
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
| Date | Feb 7, 2020 (initiated Jan 9, 2020) |
| Status | Terminated |
| Reason | The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth. |
| Root cause | Process control |
| Action | Letters sent to customers/users to immediately discontinue use and quarantine any products with the affected product code and lot numbers and return them to the manufacturer. |
| Quantity | 338,928 (199,018 US and 139,910 OUS) for all products |
| Distribution | Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.