The Recall Desk
HighFDA (Devices)·Z-0302-2023·Announced 2022-11-30

Surgical Convenience Kits with Recalled 3M Surgical Drapes

ROi CPS LLC is recalling 21 surgical convenience kits distributed to Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that were subsequently recalled.

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: FDA Class II recall of a medical device (surgical drape) inherently used in surgical procedures, qualifying as a risk-of-harm product. No reported illnesses or injuries are documented, and the specific defect is not detailed in this notice.

Plain-English summary

ROi CPS LLC is recalling surgical convenience kits (model NU00974F, Item Number 800769006) that were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. A total of 21 kits were distributed. The affected lot is 91584 with an expiration date of September 2023.

The kits were recalled because they contain 3M surgical drapes, which were subsequently recalled. The specific reason for the 3M surgical drape recall is not provided in this notice.

Healthcare facilities that received these kits should consult the original 3M surgical drape recall information for details about the defect and appropriate actions regarding the affected kits.

The recalled product

Product
regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical / Surgical Drapes
Hazard
  • device-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 10194717114062
  • Lot Numbers: 91584
  • exp 9/23/2023

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC

Related recalls

Same category