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Recall Observatory FDA recall evidence

Device product

LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region

Z-3212-2017

July 05, 2017

Class II

Product summary

Firm
Teleflex Medical
Event
Event 77980
Status
Terminated
Classification
Class II
Quantity
135,456 units
Official record key
device-enforcement:Z-3212-2017

Official wording

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

Code information: Lot Numbers: (a) MAD600 MADgic: 161217, 161218, 161228 (b) MAD700 MADgic: 161119, 161120, 161121, 161153, 161173, 161212, 161223, 161236 (c) MAD720 MADgic: 161154

Distribution pattern: Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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