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Recall Observatory FDA recall evidence

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

Z-1628-2018

March 19, 2018

Class II

Product summary

Firm
Teleflex Medical Europe Ltd
Event
Event 79643
Status
Terminated
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-1628-2018

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 Number 161212

Distribution pattern: TX

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.