Teleflex Medical recalls LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control…

Recall date

January 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1085-2015

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

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.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.