Recall Z-0275-2014— DeRoyal Industries Inc
Class II · Terminated
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2013-08-12, terminated 2014-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-12
- Terminated
- 2014-08-04
- Firm location
- Powell, TN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.