Reported Jan 3, 2024 · Ongoing

DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

DeRoyal Industries Inc.

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: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703

Is this the product you have?

  • DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Lot codes and dates
  • GTIN 00749756364065
  • Serial Numbers
    • '59716839
    • '59867186
Amount recalled
252 units

Where it was sold

Why it was recalled

Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

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

Data as of Sep 19, 6:55 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.