FDA Enforcement
Class II
Ongoing
GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
Recall: Z-0605-2023
·
Reported December 21, 2022
Enforcement
- Recall Number
- Z-0605-2023
- 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
GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
Reason
XXX
Code Info
Lot Numbers: Lot 56189375 exp 10/1/2024; Lot 56392381 exp 10/1/2024; Lot 56618504 exp 11/1/2024; Lot 57392455 exp 2/1/2025; Lot 5775963 exp 4/1/2025
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
243 kits