The Recall Desk
HighFDA (Devices)·Z-0292-2023·Announced 2022-11-30

Neurosurgery Kits Recalled Due to Defective 3M Surgical Drapes

ROi CPS LLC is recalling 38 neurosurgery convenience kits distributed in four states because they contain 3M surgical drapes that were separately recalled.

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 recall for neurosurgery kits, which are risk-of-harm medical devices used in patient care. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High rating. No illnesses or injuries are reported in the source material.

Plain-English summary

ROi CPS LLC is recalling 38 regard CERVICAL PACK neurosurgery convenience kits (Item Number 800058008) distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subsequently recalled.

The affected lot numbers are 91577 (with expiration date 2/7/2023) and 91382 (with expiration date 12/7/2023). Recipients of these kits should discontinue use.

The recalled product

Product
regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Kit
Hazard
Affected units
38

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 (5)

  • UDI/DI 10174717108863
  • Lot Numbers: 91577
  • exp 2/7/2023
  • 91382
  • exp 12/7/2023

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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