FDA Enforcement
Class II
Terminated
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
Recall: Z-0275-2014
·
Reported November 20, 2013
Enforcement
- Recall Number
- Z-0275-2014
- Event ID
- 66608
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- DeRoyal Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 20, 2013
- Initiation Date
- August 12, 2013
- Classification Date
- November 14, 2013
- Termination Date
- August 4, 2014
- Address
- 200 Debusk Ln, Powell, TN, 37849-4703, United States
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
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Code Info
Lot Number 32794811
Distribution
Nationwide Distribution
Quantity
726 cases (7242 units)