—#171824

Product

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

FDA product code: BTR — Tube, Tracheal (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K935842
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2019-04-01
Terminated: 2025-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171824. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.