FDA Enforcement
Class II
Ongoing
DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
Recall: Z-0563-2023
·
Reported December 21, 2022
Enforcement
- Recall Number
- Z-0563-2023
- Event ID
- 91134
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DeRoyal Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 21, 2022
- Initiation Date
- November 3, 2022
- Classification Date
- December 15, 2022
- Address
- 200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States
Description
DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
Reason
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
Code Info
Lot Numbers: Lot 56394918 exp 11/3/2024; Lot 56778591 exp 12/1/2024
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
Quantity
130 kits