Reported Nov 20, 2013 · Terminated

DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane,…

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) Surgical Eye Spears, REF 30-049, Sterile EO
  • ManufacturerDeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
Lot codes and dates
  • Lot Number 32794811
Amount recalled
726 cases (7242 units)

Where it was sold

  • Nationwide

Why it was recalled

One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.

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 Aug 4, 2014 · Data as of Sep 19, 4:51 PM UTC

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