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
Reported: November 20, 2013 Initiated: August 12, 2013 #Z-0275-2014
Product Description
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
Reason for Recall
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 726 cases (7242 units)
- Distribution
- Nationwide Distribution
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by DeRoyal Industries Inc. Units affected: 726 cases (7242 units).
Why was this product recalled? ▼
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0275-2014.
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