The Recall Desk
ModerateFDA (Devices)·Z-0306-2023·Announced 2022-11-30

Surgical Convenience Kits Containing Recalled 3M Surgical Drapes

Eye surgery convenience kits containing 3M surgical drapes that were separately recalled are being recalled. Affected units 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: This is an FDA Class II recall with no reported illnesses or injuries. The convenience kits are being recalled on a precautionary basis because they contain 3M surgical drapes that were subject to a separate recall.

Plain-English summary

The ¿regard EYE TRAY surgical convenience kits (Item Number 880099031) manufactured by ROi CPS LLC are being recalled because they contain 3M surgical drapes that were subject to a separate recall.

A total of 258 kits are affected. These products were distributed in Louisiana, Missouri, North Carolina, and Florida. Affected units are identified by lot numbers 92643 (expiration 5/24/2024), 93393 (expiration 8/18/2024), and 93669 (expiration 9/26/2024), and can be confirmed using UDI/DI 10194717113485.

Hospitals, surgical centers, and other facilities with affected kits should not use them. Contact ROi CPS LLC for further instructions regarding return, replacement, or disposal of recalled products.

The recalled product

Product
¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye 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 10194717113485
  • Lot Numbers: 92643
  • exp 5/24/2024
  • 93393
  • exp 8/18/2024
  • 93669
  • exp 9/26/2024

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC