FDA recall Z-0296-2023

ROi CPS LLC · Class II · device

Product

regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit

Reason for recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Distribution

LA, MO, NC, FL

Key facts

Status
Terminated
Initiation date
2022-10-20
Report date
2022-11-30
Termination date
2026-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0296-2023