—#132646

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.

FDA product code: CAE — Airway, Oropharyngeal, Anesthesiology
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Catalog No(s): 175050, Lot no. HMAUGK

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).

Root cause (FDA determination)

Other

Action the firm took

Teleflex sent an Urgent Medical Device Recall Notification letter dated January 13, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products and to return it to Teleflex Medical. Customers were asked to complete the enclosed Recall Acknowledgement Form via fax even if they do not have the affected product in stock. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-01-13
Posted by FDA: 2015-02-10
Terminated: 2016-09-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132646. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.