Reported May 18, 2022 · Terminated

Regard brand CABG Pack A and B - Spartanburg

ROi CPS LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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 brand CABG Pack A and B - Spartanburg
Lot codes and dates
  • Item Number800208017
  • Lot 91156 UDI(01)10194717112495(17)230101(10)91156
Amount recalled
85 kits

Where it was sold

Why it was recalled

Kits were packed into shipping boxes incorrectly.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 28, 2023 · Data as of Sep 19, 6:20 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.