Z-0321-2023 Class II Terminated
FDA device recall Z-0321-2023 was initiated by ROi CPS LLC on Oct 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 Apr 1, 2026). Affected quantity: 302 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 30, 2022
- Initiation Date
- Oct 20, 2022
- Termination Date
- Apr 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 302 kits
Product Description
regard SPINE, OR01100A, Item Number 880468001; ortho 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 10194717113713, Lot Numbers: 91240, exp 8/3/2023; 92740, exp 2/14/2024
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0321-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026