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

FDA device recall Z-1085-2015 · posted 2015-02-10 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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).

Action taken

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.

Root cause

Other

Status

Terminated

Product code

CAE

Quantity affected

2640 units

Distribution

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.

Date initiated

2015-01-13

Date posted

2015-02-10

Date terminated

2016-09-27

Location

Research Triangle Park, NC