Recall Z-1116-2020
Teleflex Medical Inc · initiated January 9, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Codes / lots: Product Code 004551003; Lot Numbers 1811331, 1902331, 1904331
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1116-2020
- Initiated
- January 9, 2020
- Posted by FDA
- February 7, 2020
- Terminated
- September 11, 2023
- Product code
- CCW – Laryngoscope, Rigid
- 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
- Recalling firm
- Teleflex Medical Inc, Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1117-2020 Class II | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic SystemThe products are being recalled due to reports of breakage broke at the point of a welded joint either prior… | 01/09/2020Terminated |