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Recall Observatory FDA recall evidence

Device product

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

Z-0941-2022

March 09, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
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

    reason.no_named_rule · v1.0.0

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