FDA recall Z-1628-2018

Teleflex Medical Europe Ltd · Class II · device

Product

Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region

Reason for recall

Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

Distribution

TX

Key facts

Status
Terminated
Initiation date
2018-03-19
Report date
2018-05-09
Termination date
2019-08-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athlone, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1628-2018