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Recall Observatory FDA recall evidence

Device product

DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15

Z-0561-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
828 kits
Official record key
device-enforcement:Z-0561-2023

Official wording

Reason: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.

Code information: Lot Numbers: Lot 56185163 exp 2/1/2024; Lot 56390466 exp 2/1/2024; Lot 56616859 exp 2/1/2024; Lot 57390901 exp 1/1/2024; Lot 57466813 exp 10/1/2024; Lot 57589987 exp 6/1/2024; Lot 57674444 exp 6/1/2024

Distribution pattern: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.