FDA-Device2015-02-18Class II
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.
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).
Sold states
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.
Affected count
2640 units
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1085-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief