Z-0286-2023 Class II Terminated
FDA device recall Z-0286-2023 was initiated by ROi CPS LLC on October 20, 2022 and is designated Class II. Reason for recall: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. The recall status is terminated (terminated April 1, 2026). Affected quantity: 18 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2022
- Initiation Date
- October 20, 2022
- Termination Date
- April 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 kits
Product Description
regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit
Reason for Recall
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Distribution Pattern
LA, MO, NC, FL
Code Information
UDI/DI 10194717109723, Lot Numbers: 91417, exp 2/2/2024