Reported Jan 10, 2024 · Terminated

Regard Dressing change kit, Item Number 800026006

ROi CPS LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ROi CPS LLC · 3000 E Sawyer Rd · Republic, MO · 65738-2758

Is this the product you have?

  • Regard Dressing change kit, Item Number 800026006
Lot codes and dates
  • UDI/DI 10194717107873
  • Lot Numbers
    • 98283
    • 97591
    • 97405
    • 97081
    • 96961
    • 95508
    • 94769
    • 94435
    • 94270
Amount recalled
1830 units

Where it was sold

  • Nationwide
  • LA

Why it was recalled

Stop using this product now

ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 5, 2024 · Data as of Sep 19, 7:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.