FDA recall Z-1685-2019

Teleflex Medical · Class II · device

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2019-04-01
Report date
2019-06-05
Termination date
2025-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1685-2019