FDAJanuary 13, 2015device
LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situatio...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff).
What to do
FDA enforcement status: Terminated
Brands named
teleflex medicalteleflex
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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