FDA recall Z-0941-2022

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Completed
Initiation date
2022-03-09
Report date
2022-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

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