Device product

DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07

Z-0563-2023

November 03, 2022

Class II

Product summary

Firm: DeRoyal Industries Inc
Event: Event 91134
Status: Ongoing
Classification: Class II
Quantity: 130 kits
Official record key: device-enforcement:Z-0563-2023

Official wording

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

Code information: Lot Numbers: Lot 56394918 exp 11/3/2024; Lot 56778591 exp 12/1/2024

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.