The Recall Desk
ModerateFDA (Devices)·Z-0287-2023·Announced 2022-11-30

Surgical convenience kits recalled for containing 3M surgical drapes

ROi CPS LLC is recalling 190 units of regard BASIC NEURO surgical convenience kits distributed in LA, MO, NC, and FL. The kits contained 3M surgical drapes that were subsequently recalled.

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 medical device recall with no reported illnesses or injuries. The specific hazard associated with the included 3M surgical drapes is not disclosed in this notice, making the risk theoretical.

Plain-English summary

ROi CPS LLC is recalling regard BASIC NEURO, NU00259R surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled.

The recalled kits (Lot Number 91329, expiration date 11/27/2022) were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. A total of 190 units were affected.

The source recall notice does not specify the underlying hazard or defect associated with the 3M surgical drapes included in these kits.

The recalled product

Product
regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
Manufacturer
ROi CPS LLC
Hazard
  • surgical-drape-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 10194717109914
  • Lot Numbers: 91329
  • exp 11/27/2022

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC