The Recall Desk
HighFDA (Devices)·Z-0285-2023·Announced 2022-11-30

Surgical Convenience Kits Recalled Due to Included Recalled Surgical Drapes

ROi CPS LLC is recalling 326 regard TOTAL JOINT surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contain 3M surgical drapes that were previously recalled. No illnesses or injuries have been reported.

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: This is an FDA Class II medical device recall of surgical equipment. The kits contain previously recalled surgical drapes, which present a risk of harm in a surgical setting. No injuries or illnesses have been reported, and the specific hazard is not detailed in the source text.

Plain-English summary

ROi CPS LLC is recalling 326 units of the regard TOTAL JOINT surgical convenience kit (Item Number 880291, Lot Numbers 91014, 92342, and 91672). The kits were distributed containing 3M surgical drapes that were subsequently recalled.

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

The specific reason for the 3M surgical drape recall is not detailed in this notice. The affected product lot numbers have the following expiration dates: Lot 91014 expires May 1, 2023; Lot 92342 expires July 1, 2023; and Lot 91672 expires July 1, 2023.

The recalled product

Product
regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic 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 (6)

  • UDI/DI 10194717104605
  • Lot Numbers: 91014
  • exp 05/01/2023
  • 92342
  • exp 07/01/2023
  • 91672

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC