The Recall Desk
ModerateFDA (Devices)·Z-0289-2023·Announced 2022-11-30

Surgical convenience kits recalled due to included 3M surgical drapes

Surgical convenience kits are being recalled because they contain 3M surgical drapes that were previously recalled. A total of 164 units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

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 illnesses, injuries, or deaths. This is a precautionary recall addressing kits containing previously-recalled surgical drapes; the specific hazard is not detailed in the source text.

Plain-English summary

ROi CPS LLC is recalling surgical convenience kits (regard SPINE PACK, model NU00260H) that contain 3M surgical drapes which were previously recalled. A total of 164 units were distributed to surgical facilities in Louisiana, Missouri, North Carolina, and Florida.

The source text does not specify what defect or issue prompted the original 3M surgical drape recall, only that the drapes were subsequently recalled. Because these drapes were included in the surgical convenience kits, the kits are being recalled as a secondary consequence. This is an FDA Class II recall.

The recalled product

Product
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
Manufacturer
ROi CPS LLC
Hazard
  • product-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 (5)

  • UDI/DI 10194717108849
  • Lot Numbers: 91281
  • exp 5/28/2023
  • 91103
  • exp 10/11/2023

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC