FDA Device

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

Hazard

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

What You Should Do

Remedy

The firm initiated the recall by letter on 04/01/2019. The letter stated reason for the recall and requested the return of the recalled units. Distributors were directed to collect the recalled units from their customers, consolidate them, and complete and return the acknowledgement form. The recalled units will be returned.

Products

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

Units Affected

1787 units