Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
FDA device recall Z-1116-2020 · posted 2020-02-07 · Terminated
Recall details
- Recalling firm
- TELEFLEX MEDICAL INC
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CCW
- Quantity affected
- 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
- Date initiated
- 2020-01-09
- Date posted
- 2020-02-07
- Date terminated
- 2023-09-11
- Location
- Morrisville, NC
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