Recall Z-1683-2019

Teleflex Medical · initiated April 1, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0

Codes / lots: Lot Numbers: 14151, 14161, 14171, 14201, 14211, 14231, 14261, 14271, 14291, 14451, 14461, 14491, 14511, 15041, 15081, 15091, 15101, 15131, 15161, 15201, 15211, 15221, 15241, 15251, 15361, 15381, 15391, 15411, 15431, 15441, 15461, 15491, 15501, 16041, 16051, 16061, 16081, 16091, 16111, 16121, 16141, 16161, 16171, 16191, 16201, 16221, 16231, 16241, 16251, 16261, 16281, 16291, 16301, 16351, 16361, 16371, 16381, 16391, 16401, 16421, 16431, 16441, 16451, 16471, 16481, 16501, 16511, 17021, 17041, 17051, 17061, 17071, 17081, 17091, 17101, 17121, 17131, 17161, 17171, 17181, 17191, 17201, 17211, 17231, 17271, 17281, 17301, 17311, 17361, 17371, 17391, 17421, 17431, 17441, 17451, 17461, 17471, 17481, 17491, 17501, 17511, 18021, 18031, 18041, 18051, 18061, 18071, 18081, 18091, 18101, 18111, 18121, 18131, 18141, 18151, 18171, 18191, 18201, 18231, 18241, 18271, 18351, 18361, 18381, 18401, 18421, 18431, 18441, 14141, 14161, 14171, 14201, 14211, 14231, 14261, 14271, 14281, 14291, 14301, 14311, 14361, 14431, 14441, 14461, 14471, 14481, 14501, 14511, 15041, 15051, 15071, 15081, 15091, 15111, 15121, 15161, 15191, 15211, 15231, 15251, 15311, 15361, 15371

Reason for recall

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

FDA-determined cause: Process control

Action taken

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.

Details

Recall number
Z-1683-2019
Initiated
April 1, 2019
Terminated
June 3, 2025
Product code
BTR – Tube, Tracheal (W/Wo Connector)
Quantity
5995 units
Distribution
Nationwide
Recalling firm
Teleflex Medical, Morrisville, NC

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1682-2019 Class IIRUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0The firm received reports indicating that the laser guard foil partially separated and/or slightly detached… 04/01/2019Terminated
Z-1684-2019 Class IIRUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0The firm received reports indicating that the laser guard foil partially separated and/or slightly detached… 04/01/2019Terminated
Z-1685-2019 Class IIRUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0The firm received reports indicating that the laser guard foil partially separated and/or slightly detached… 04/01/2019Terminated
Z-1686-2019 Class IIRUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0The firm received reports indicating that the laser guard foil partially separated and/or slightly detached… 04/01/2019Terminated