Recall Z-1628-2018— Teleflex Medical Europe Ltd

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical Europe Ltd, initiated 2018-03-19, terminated 2019-08-27. FDA's recall record names no specific 510(k) clearance for this event. 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: Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label..

Recalling firm
Teleflex Medical Europe Ltd
Classification
Class II
Status
Terminated
Initiated
2018-03-19
Terminated
2019-08-27
Firm location
Athlone, N/A, Ireland

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.