Z-1682-2019 Class II Terminated
FDA device recall Z-1682-2019 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: 1787 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
- 1787 units
Product Description
RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
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, 14171, 14211, 14231, 14271, 14281, 14321, 14441, 14461, 14501, 14511, 15031, 15051, 15091, 15101, 15251, 15271, 15411, 16051, 16071, 16101, 16161, 16171, 16201, 16231, 16271, 16291, 16301, 16311, 16361, 16381, 16401, 16421, 16431, 16451, 16481, 16501, 16511, 17021, 17031, 17051, 17071, 17091, 17111, 17121, 17161, 17181, 17191, 17201, 17251, 17261, 17271, 17281, 17351, 17371, 17461, 18021, 18031, 18061, 18101, 18121, 18161, 18201, 18351, 18361, 18401