DeRoyal KIT EXTREMITY PACK, REF 89-8869.09
FDA Recall #Z-0628-2023 — Class II — November 3, 2022
Product Description
DeRoyal KIT EXTREMITY PACK, REF 89-8869.09
Reason for Recall
XXX
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
75 kits
Distribution
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
Code Information
Lot Numbers: Lot 56390950 exp 6/1/2026; Lot 56837871 exp 9/1/2026; Lot 5718781 exp 10/1/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.