Device 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
Z-0275-2014
Product summary
- Event
- Event 66608
- Status
- Terminated
- Classification
- Class II
- Quantity
- 726 cases (7242 units)
- Official record key
device-enforcement:Z-0275-2014
Official wording
Reason: One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Code information: Lot Number 32794811
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Labeling or packaging
labeled as being x-ray detectable, but contained