The Recall Desk
ModerateFDA (Devices)·Z-0296-2023·Announced 2022-11-30

Surgical Convenience Kits Recalled Due to Included 3M Drape Components

Orthopaedic surgical convenience kits distributed in four states contained 3M surgical drapes that were subsequently recalled. ROi CPS LLC is recalling 38 affected kits.

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 medical device recall with no reported illnesses, injuries, or hospitalizations. The recall is precautionary in nature due to inclusion of previously recalled 3M drape components.

Plain-English summary

ROi CPS LLC is recalling regard HAND PACK surgical convenience kits (OR00594K, Item Number 800243011) distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subsequently recalled.

Thirty-eight surgical convenience kits with Lot Number 92200 and an expiration date of April 14, 2024 are affected. These kits can be identified by UDI/DI 10194717110682. Healthcare facilities and individuals who have received these kits should contact ROi CPS LLC.

The recalled product

Product
regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit
Manufacturer
ROi CPS LLC
Category
Medical Device — Orthopaedic Surgical
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 (3)

  • UDI/DI 10194717110682
  • Lot Numbers: 92200
  • exp 4/14/2024

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 →

Related recalls

Same manufacturer · ROi CPS LLC

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