The Recall Desk
ModerateFDA (Devices)·Z-0314-2023·Announced 2022-11-30

Surgical convenience kits recalled due to included recalled drape components

Surgical convenience kits containing 3M surgical drapes that were subsequently recalled have been pulled from distribution in LA, MO, NC, and FL. Affected lot numbers are 91465 (exp 2/7/2024) and 92444 (exp 5/5/2024).

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 precautionary recall with no reported illnesses or injuries. The kits are being recalled as a containment measure because they contain surgical drapes that were subsequently recalled, though the specific nature of the defect is not detailed in this notice.

Plain-English summary

Regard MINOR DAVINCI PACK surgical convenience kits (Item Number 880251013, UDI/DI 10194717104322) have been recalled by ROi CPS LLC. A total of 268 kits were distributed.

The recall was issued because these kits contain 3M surgical drapes that were subsequently recalled. The affected lot numbers are 91465 (expiration 2/7/2024) and 92444 (expiration 5/5/2024).

The kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

Healthcare providers and facilities that received affected kits should verify the lot number of their inventory and discontinue use of affected lots. Contact ROi CPS LLC for instructions on return or proper disposal.

The recalled product

Product
regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
Manufacturer
ROi CPS LLC
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 10194717104322
  • Lot Numbers: 91465
  • exp 2/7/2024
  • 92444
  • exp 5/5/2024

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC