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Recall Observatory FDA recall evidence

Device product

RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0

Z-1682-2019

April 01, 2019

Class II

Product summary

Firm
Teleflex Medical
Event
Event 82552
Status
Terminated
Classification
Class II
Quantity
1787 units
Official record key
device-enforcement:Z-1682-2019

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, 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

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.