The Recall Desk
HighFDA (Devices)·Z-0312-2023·Announced 2022-11-30

Neurosurgery convenience kits recalled due to included recalled surgical drapes

ROi CPS LLC is recalling 248 regard NEURO TRAY neurosurgery convenience kits because they contain 3M surgical drapes that were previously recalled. The kits were distributed in LA, MO, NC, and FL.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of surgical equipment used in critical neurosurgery procedures. This qualifies as a risk-of-harm product where no illnesses or injuries have been reported, placing it at the maximum score of 3 per the rubric.

Plain-English summary

ROi CPS LLC is recalling 248 regard NEURO TRAY (NU00160R, Item Number 880158018) neurosurgery convenience kits. The recall is due to the inclusion of 3M surgical drapes that were the subject of a separate product recall.

The affected kits were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. The affected lot numbers are 91174 (expiration 10/18/2023), 91908 (expiration 2/2/2024), and 92566 (expiration 2/14/2024).

The recalled product

Product
regard NEURO TRAY, NU00160R, Item Number 880158018; neuro 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 10194717113331
  • Lot Numbers: 91174
  • exp 10/18/2023
  • 91908
  • exp 2/2/2024
  • 92566
  • exp 2/14/2024

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC