DeRoyal CRANI PACK, REF 89-10242.04
FDA Recall #Z-0684-2023 — Class II — November 3, 2022
Product Description
DeRoyal CRANI PACK, REF 89-10242.04
Reason for Recall
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8 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 5688188 exp 8/1/2023
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated