Device 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.
Z-1085-2015
Product summary
- Firm
- Teleflex Medical
- Event
- Event 70258
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2640 units
- Official record key
device-enforcement:Z-1085-2015
Official wording
Reason: 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).
Code information: Catalog No(s): 175050, Lot no. HMAUGK
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.
Derived failure modes
-
Unknown
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).