Device product
RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
Z-1686-2019
Product summary
- Firm
- Teleflex Medical
- Event
- Event 82552
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2325 units
- Official record key
device-enforcement:Z-1686-2019
Official wording
Reason: The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
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
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.