Recall Z-0275-2014 ยท HOZ Sponge, Ophthalmic
DeRoyal Industries Inc
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
| Date | Nov 14, 2013 (initiated Aug 12, 2013) |
| Status | Terminated |
| Reason | One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product. |
| Root cause | Employee error |
| Action | DeRoyal Industries sent an Urgent Voluntary Recall letter dated August 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease usage and return the product to: DeRoyal Recalls RA#: Eye Spears 1755 Hwy 33 South New Tazewell, TN 37825 Ship via UPS Ground using Shipper #312780 Distributors were requested to notify their consignees of the same. The recall is extended to the user level. Customers with questions were instructed to call 1-800-251-9864. For questions regarding this recal |
| Quantity | 726 cases (7242 units) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.