Recall Z-0313-2023— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2022-10-20, terminated 2026-04-01. FDA's recall record names no specific 510(k) clearance for this event. Product: regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit. Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-10-20
- Terminated
- 2026-04-01
- Firm location
- Republic, MO, United States
Product description
regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
Reason for recall
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.