FDA-Device2022-12-21Class II
DeRoyal CATARACT PACK CSM, REF 89-6863
DeRoyal Industries Inc
Hazard
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Sold states
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
Affected count
1220 kits
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal CATARACT PACK CSM, REF 89-6863
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0580-2023Don't want to check this manually?
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