The Recall Desk
ModerateFDA (Devices)·Z-0320-2023·Announced 2022-11-30

Hip Arthroscopy Surgical Convenience Kits Recalled Containing Recalled Drapes

ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.

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: This is an FDA Class II recall with no reported illnesses or injuries. The recall is precautionary, initiated because the kits contain surgical drapes that were themselves subject to recall.

Plain-English summary

ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits (Item Number 880462002, UDI/DI 10194717109426). This recall was initiated because the kits contain 3M surgical drapes which were subsequently recalled.

Twenty-four surgical convenience kits were distributed to locations in Louisiana, Missouri, North Carolina, and Florida. The affected lot numbers are 90993 (expiration date 10/11/2023) and 91722 (expiration date 1/12/2024).

Persons with access to these kits should be aware that they contain surgical drape components that were subject to recall and should not be used for their intended purpose.

The recalled product

Product
regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho 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 (5)

  • UDI/DI 10194717109426
  • Lot Numbers: 90993
  • exp 10/11/2023
  • 91722
  • exp 1/12/2024

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC