FDA-Device2013-11-20Class II
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
DeRoyal Industries Inc
Hazard
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Sold states
Nationwide Distribution
Affected count
726 cases (7242 units)
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0275-2014Don't want to check this manually?
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