Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
FDA Recall Z-0941-2022 · Posted None
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusTerminated
Product CodeCAE
Date Initiated2022-03-09
Date Terminated2026-05-26
Product Quantity8990 cases
Reason for Recall
The mask cuff may disconnect from the device's breathing tube.
Firm Action
Medline Industries, Inc. notified all affected consignees via first class mail on March 8, 2022.
Medline Industries, LP. has provided each consignee with a letter and a Destruction form to record their response to the recall notification. Each Response received will be recorded and Medline Industries, LP. will send subsequent letters to consignees that have not provided a response to our recall notification in the allotted time.
Each consignee was provided with a destruction form to complete and return. The consignees are responsible to destroy their product per their local and state regulations. No product will be returned to be stored.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.