FDAFDA · Food and drugs·Recall number Z-0565-2023
DeRoyal PEDI ORTHO PACK, REF 89-5323.20
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 56181816 exp 10/1/2023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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