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Recall Observatory FDA recall evidence

Device product

RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0

Z-1685-2019

April 01, 2019

Class II

Product summary

Firm
Teleflex Medical
Event
Event 82552
Status
Terminated
Classification
Class II
Quantity
4312 units
Official record key
device-enforcement:Z-1685-2019

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: 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

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.