The Recall Desk
ModerateFDA (Devices)·Z-0295-2023·Announced 2022-11-30

Recall of Surgical Convenience Kits Containing Recalled 3M Drapes

ROi CPS LLC is recalling 258 surgical convenience kits containing 3M surgical drapes that were subject to a subsequent recall. The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

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 of surgical convenience kits with no reported hospitalizations, injuries, or illnesses. The specific hazard associated with the recalled drapes is not detailed in the source material.

Plain-English summary

ROi CPS LLC is recalling 258 surgical convenience kits (regard SPINE PACK, Item Number 800241010) distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subsequently recalled by their manufacturer.

The affected lot numbers are 92051 (expiration 7/1/2023) and 91671 (expiration 1/29/2024). The FDA has classified this as a Class II recall. The source notice does not specify the defect or hazard associated with the recalled drapes.

Affected healthcare facilities and patients should contact ROi CPS LLC or their healthcare provider for guidance on handling these kits.

The recalled product

Product
regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit
Manufacturer
ROi CPS LLC
Hazard
  • defective-surgical-drape

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 10194717110767
  • Lot Numbers: 92051
  • exp 7/1/2023
  • 91671
  • exp 1/29/2024

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC