Reported Sep 7, 2016 · Terminated

DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,

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 (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Lot codes and dates
  • Lot Number 40004006
Amount recalled
24 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.

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 Jun 13, 2017 · Data as of Sep 19, 6:46 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.