FDA recall Z-0705-2018

Teleflex Medical · Class II · device

Product

Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

Reason for recall

The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain RUSCH GREEN LITE MAC 2.

Distribution

US only

Key facts

Status: Terminated
Initiation date: 2017-01-10
Report date: 2018-03-07
Termination date: 2021-04-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Research Triangle Park, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0705-2018