FDA-Device2022-04-20Class II

Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

MEDLINE INDUSTRIES, LP - Northfield
Hazard

The mask cuff may disconnect from the device's breathing tube.

Sold states
US Nationwide distribution.
Affected count
8990 cases
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0941-2022

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