Device product
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Z-0941-2022
Product summary
- Event
- Event 89821
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8990 cases
- Official record key
device-enforcement:Z-0941-2022
Official wording
Reason: The mask cuff may disconnect from the device's breathing tube.
Code information: 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)
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The mask cuff may disconnect from the device's breathing tube.