Z-1686-2019 Class II Terminated
FDA device recall Z-1686-2019 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: 2325 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
- 2325 units
Product Description
RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
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: 14151, 14161, 14201, 14281, 14301, 14321, 14431, 14491, 14511, 15041, 15371, 15441, 16071, 16131, 16191, 16221, 16241, 16271, 16311, 16371, 16391, 16441, 16451, 16481, 16491, 17091, 17121, 17181, 17211, 17241, 17281, 17351, 17381, 17451, 17471, 17491, 18181, 18301, 18411