The Recall Desk
ModerateFDA (Devices)·Z-0313-2023·Announced 2022-11-30

Surgical Convenience Kits Recalled Due to Defective Component Drapes

ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits that contain 3M surgical drapes subject to a separate FDA recall. The affected lots should be removed from use.

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 with no reported injuries or illnesses. The kits are being removed due to containing surgical drapes subject to a separate recall. This is a precautionary recall with no indication of clinical harm.

Plain-English summary

ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits (Item Number 880179014) used in neurosurgery. The kits contain 3M surgical drapes that were subject to a subsequent FDA recall. The kits were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

The affected lot numbers are: 92239 (expiration 11/27/2023) and 91440 (expiration 12/7/2023). The universal device identifier (UDI/DI) is 10194717109457.

Healthcare facilities that received these kits should stop using them immediately and contact ROi CPS LLC. Check your inventory against the lot numbers and UDI provided. Do not use any kits with the affected lot numbers.

The recalled product

Product
regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Equipment
Hazard
  • defective-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 (5)

  • UDI/DI 10194717109457
  • Lot Numbers: 92239
  • exp 11/27/2023
  • 91440
  • exp 12/7/2023

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC

Related recalls

Same category