FDAFDA · Food and drugs·Recall number Z-0580-2023
DeRoyal CATARACT PACK CSM, REF 89-6863
Published December 21, 2022 · Recall initiated: November 3, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- 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
- Lot
- Lot Numbers: Lot 55807995 exp 1/1/2023; lot 56029890 exp ***; lot 57001098 exp ***; lot 57198118 exp ***; lot 56613261 exp ***
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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