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Teleflex Medical recalls LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain con
Recalled February 18, 2015 · FDA recall Z-1085-2015 · Teleflex Medical
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). · FDA Class II
Units
2640 units
Sold at
Worldwide Distribution - U.S Nationwide in the states of: AZ, CA, DE, FL, GA, IL, KY, MO, NY, OK, PA, TX, VA & WA and the country of Canada.
Description
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).
Product
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 situation and the cannot-intubate-cannot-ventilate situation.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →