FDA recall Z-0303-2023

ROi CPS LLC · Class II · device

Product

¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac 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-0303-2023