The Recall Desk
ModerateFDA (Devices)·Z-0310-2023·Announced 2022-11-30

Surgical Convenience Kits Recalled for Included 3M Surgical Drapes

ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.

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: FDA Class II recall with no reported injuries or illnesses. The kits contained 3M surgical drapes that were separately recalled, but the source does not specify the underlying hazard or report any patient complications.

Plain-English summary

ROi CPS LLC is recalling regard DAVINCI PACK surgical convenience kits (Item Number 880132023) used in gastric surgery procedures. The company distributed 228 kits in Louisiana, Missouri, North Carolina, and Florida.

The kits were recalled because they contained 3M surgical drapes that were subject to a separate recall. The specific hazard associated with the 3M drapes is not detailed in this notice.

Affected kits carry the following lot numbers with their expiration dates: Lot 90987 (expiration 12/28/2023), Lot 91804 (expiration 3/18/2024), and Lot 92715 (expiration 6/6/2024). Healthcare facilities that received these kits should verify their inventory and contact the manufacturer for guidance.

If you have received any of these kits, contact ROi CPS LLC for return or replacement instructions. Do not use the surgical drapes included in these kits. No patient injuries have been reported.

The recalled product

Product
regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
Manufacturer
ROi CPS LLC
Hazard
  • recalled-component

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 (7)

  • UDI/DI 10194717113119
  • Lot Numbers: 90987
  • exp 12/28/2023
  • 91804
  • exp 3/18/2024
  • 92715
  • exp 6/6/2024

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC