Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
- Recall Initiated
- March 9, 2022
- Recall Number
- Z-0941-2022
- Quantity
- 8990 cases
- Firm Location
- Northfield, IL
Reason for Recall
The mask cuff may disconnect from the device's breathing tube.
Distribution
US Nationwide distribution.
Lot / Code Info
Medline Item Number and Lot(s): 1) DYND290010; Lot 63521050001 (UDI: 10193489036688) 2) DYND290015; Lot 63521050001 (UDI: 10193489036695) 3) DYND290020; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036701) 4) DYND290025; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036718) 5) DYND290030; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036725) 6) DYND290040; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036732) 7) DYND290050; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036749)
Root Cause
Process control
Action Taken
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.