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FDAFDA · Food and drugs·Recall number Z-0275-2014

DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye

Published November 20, 2013 · Recall initiated: August 12, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
DeRoyal Industries Inc
Distributor
Nationwide Distribution
Lot
Lot Number 32794811
Risk classification
Class II
Area (FDA)
device
Country
United States

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