The Recall Desk
ModerateFDA (Devices)·Z-0307-2023·Announced 2022-11-30

Surgical Convenience Kits Recalled Due to Recalled 3M Surgical Drapes

ROi CPS LLC is recalling 243 surgical convenience kits that contain recalled 3M surgical drapes. The kits were distributed in four states.

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, injuries, or deaths. The recall is a secondary precautionary measure taken because the convenience kits contain surgical drapes that were previously recalled.

Plain-English summary

ROi CPS LLC is recalling 243 regard FOOT PACK surgical convenience kits that were distributed in Louisiana, Missouri, North Carolina, and Florida. These kits contain 3M surgical drapes that were subsequently recalled.

The FDA notice does not specify the reason for the 3M drape recall. The convenience kits are being recalled as a consequence of containing surgical drapes that have been identified for recall.

The affected kits are identified by UDI/DI 10194717114789, Lot Number 92274, with an expiration date of May 2, 2024.

The recalled product

Product
regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
Manufacturer
ROi CPS LLC
Hazard
  • product-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 (3)

  • UDI/DI 10194717114789
  • Lot Numbers: 92274
  • exp 5/2/2024

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC