The Recall Desk
ModerateFDA (Devices)·Z-0303-2023·Announced 2022-11-30

Surgical Convenience Kits Recalled Due to Defective 3M Surgical Drapes

ROi CPS LLC is recalling 108 surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida that contained 3M surgical drapes which were subsequently recalled.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries in the source material. The specific hazard associated with the 3M surgical drapes is not detailed in the FDA notice.

Plain-English summary

ROi CPS LLC is recalling 108 surgical convenience kits that contained 3M surgical drapes which were subsequently recalled. The kits were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

Affected lot numbers are 92534 (expiring 11/13/2022) and 93366 (expiring 2/28/2023), identified by UDI/DI 10194717114895. Healthcare facilities should discontinue use and contact ROi CPS LLC for replacement or disposal instructions. This is classified as a Class II recall.

The recalled product

Product
¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
Manufacturer
ROi CPS LLC
Hazard
  • surgical-device-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • UDI/DI 10194717114895
  • Lot Numbers: 92534
  • exp 11/13/2022
  • 93366
  • exp 2/28/2023

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC