Z-0705-2018 Class II Terminated
FDA device recall Z-0705-2018 was initiated by Teleflex Medical on January 10, 2017 and is designated Class II. Reason for recall: The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain RUSCH GREEN LITE MAC 2. The recall status is terminated (terminated April 13, 2021). Affected quantity: 2140 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- January 10, 2017
- Termination Date
- April 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2140 units
Product Description
Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.
Reason for Recall
The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain RUSCH GREEN LITE MAC 2.
Distribution Pattern
US only
Code Information
Lot/Serial number: 1602312