The Recall Desk
ModerateFDA (Devices)·Z-0305-2023·Announced 2022-11-30

Surgical Convenience Kits Recalled by ROi CPS Due to Included 3M Surgical Drapes

ROi CPS LLC is recalling 456 surgical convenience kits containing 3M surgical drapes that were subject to a separate recall. The kits were distributed across 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 without reported illnesses or injuries. This is a precautionary recall of surgical kits distributed with a recalled component (3M surgical drapes), with no specific hazard detailed in the source.

Plain-English summary

ROi CPS LLC is recalling 456 units of ¿regard SHOULDER ARTHROSCOPY surgical convenience kits (Item Number 880044017, UDI/DI 10194717113478) because they were distributed containing 3M surgical drapes that were subject to a subsequent recall.

The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida. Affected lot numbers are Lot 91163 (expiration 1/10/2024), Lot 91669 (expiration 2/25/2024), and Lot 92537 (expiration 5/15/2024).

The recalled product

Product
¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
Manufacturer
ROi CPS LLC

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 10194717113478
  • Lot Numbers: 91163
  • exp 1/10/2024
  • 91669
  • exp 2/25/2024
  • 92537
  • exp 5/15/2024

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC