Z-1684-2019 Class II Terminated
FDA device recall Z-1684-2019 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. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
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: 15411, 15421, 15431, 15441, 15451, 15461, 15471, 15501, 16031, 16061, 16081, 16091, 16101, 16131, 16151, 16161, 16171, 16181, 16191, 16201, 16221, 16231, 16241, 16251, 16261, 16281, 16291, 16301, 16311, 16351, 16361, 16371, 16381, 16391, 16421, 16431, 16441, 16451, 16461, 16471, 16481, 16501, 17021, 17031, 17041, 17051, 17061, 17081, 17091, 17101, 17111, 17121, 17131, 17161, 17171, 17181, 17191, 17201, 17221, 17231, 17251, 17261, 17271, 17281, 17291, 17301, 17361, 17381, 17411, 17421, 17431, 17441, 17451, 17461, 17471, 17481, 17491, 17501, 18021, 18031, 18041, 18051, 18061, 18071, 18091, 18101, 18111, 18121, 18131, 18141, 18151, 18161, 18171, 18201, 18221, 18231, 18241, 18251, 18281, 18301, 18311, 18381, 18401, 18411, 18421, 18431, 18441