The Recall Desk
HighFDA (Devices)·Z-0298-2023·Announced 2022-11-30

Surgical Convenience Kits Recalled Due to Recalled Surgical Drapes

Regard ACDF surgical convenience kits containing 3M surgical drapes that were subsequently recalled are being recalled by ROi CPS LLC. Approximately 30 kits were distributed in Louisiana, Missouri, North Carolina, and Florida.

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 FDA Class II recall involves surgical equipment with no reported illnesses or injuries. The recall of a component within surgical kits represents a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.

Plain-English summary

Regard ACDF surgical convenience kits, Item Number 800246009 (UDI 10194717110811), manufactured by ROi CPS LLC have been recalled. These surgical convenience kits for neurosurgical procedures contain 3M surgical drapes that were subsequently recalled.

The affected kits are identified by Lot Number 92354 with an expiration date of January 31, 2023. Approximately 30 kits were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

Healthcare facilities that received these kits should discontinue use and isolate the recalled kits from inventory. For more information or return instructions, contact ROi CPS LLC.

The recalled product

Product
regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Equipment
Hazard
  • surgical-drape-defect

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 10194717110811
  • Lot Numbers: 92354
  • exp 1/31/2023

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC

Related recalls

Same category