The Recall Desk
HighFDA (Devices)·Z-0318-2023·Announced 2022-11-30

Regard Shoulder surgical kits recalled due to defective included drapes

ROi CPS LLC is recalling Regard SHOULDER surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled. Affected kits were distributed to healthcare facilities in LA, MO, NC, and FL.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II FDA recall involving surgical medical devices. Surgical kits are inherent risk-of-harm products; although no patient injuries or illnesses have been reported, distributed kits present potential harm risk in clinical use.

Plain-English summary

Regard SHOULDER surgical convenience kits (Model GS00828G, Item Number 880367007) manufactured by ROi CPS LLC are being recalled. These surgical kits contain 3M surgical drapes that were found to be subject to a separate recall. Approximately 28 kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida. The affected product includes Lot Number 91778 with an expiration date of March 8, 2024, and has a UDI/DI of 10194717105121.

Healthcare facilities that have received these kits should immediately stop using them and contact ROi CPS LLC for instructions on return or disposal of the affected units.

Patients who underwent surgical procedures using these kits should contact their healthcare provider if they have concerns or experience complications potentially related to their surgical care.

The recalled product

Product
regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Kits
Hazard
Affected units
28

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 10194717105121
  • Lot Numbers: 91778
  • exp 3/8/2024

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

See all →

Same hazard · surgical drape defect

See all →