The Recall Desk
HighFDA (Devices)·Z-0311-2023·Announced 2022-11-30

Neuro surgery kits recalled for defective 3M surgical drapes

ROi CPS LLC is recalling 790 neuro surgery convenience kits that contained 3M surgical drapes which were subsequently recalled. The kits were distributed to Louisiana, Missouri, North Carolina, and Florida.

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: This is an FDA Class II medical device recall of surgical equipment containing recalled components. While no adverse health events have been reported, surgical drapes are critical for patient safety and infection control, making this a risk-of-harm product per FDA guidance.

Plain-English summary

ROi CPS LLC is recalling the regard MINOR NEURO (NU00140AD) surgical convenience kits. Approximately 790 kits were distributed to Louisiana, Missouri, North Carolina, and Florida. These kits contained 3M surgical drapes that were subsequently recalled.

The affected lot numbers are: 91012 (expiration 9/28/2023), 91752 (expiration 1/29/2024), and 92497 (expiration 2/14/2024). The specific reason for the 3M surgical drape recall is not detailed in this notice.

Healthcare facilities and surgical providers who received these kits should refer to the FDA recall database for complete information and instructions on device handling and return procedures. For more details, see FDA recall Z-0311-2023.

The recalled product

Product
regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Kit
Hazard
Affected units
790

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 10194717111306
  • Lot Numbers: 91012
  • exp 9/28/2023
  • 91752
  • exp 1/29/2024
  • 92497
  • exp 2/14/2024

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 40 recalled by ROi CPS LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 40 products in this recall →

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