Z-1685-2019 Class II Terminated
FDA device recall Z-1685-2019 was initiated by Teleflex Medical on April 1, 2019 and is designated Class II. Reason for recall: The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges. The recall status is terminated (terminated June 3, 2025). Affected quantity: 4312 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2019
- Initiation Date
- April 1, 2019
- Termination Date
- June 3, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4312 units
Product Description
RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
Reason for Recall
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
Distribution Pattern
Nationwide
Code Information
Lot Numbers: 14161, 14171, 14201, 14211, 14231, 14261, 14301, 14311, 14361, 14431, 14481, 14491, 15041, 15051, 15081, 15091, 15121, 15131, 15161, 15171, 15201, 15221, 15241, 15261, 15371, 15411, 15421, 15501, 16031, 16071, 16111, 16151, 16161, 16181, 16201, 16221, 16241, 16251, 16271, 16281, 16291, 16301, 16351, 16361, 16371, 16381, 16391, 16401, 16421, 16441, 16461, 16471, 16481, 17061, 17071, 17161, 17191, 17211, 17221, 17251, 17271, 17291, 17301, 17311, 17381, 17391, 17411, 17471, 17481, 17511, 18021, 18081, 18091, 18151, 18161, 18211, 18241, 18291, 18381, 18411, 18421, 18431, 18441