—#122717

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

FDA product code: HOZ — Sponge, Ophthalmic
Device class: Class 2
Medical specialty: Ophthalmic
Affected lot / code info: Lot Number 32794811

Why it was recalled

One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.

Root cause (FDA determination)

Employee error

Action the firm took

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 recall call 865-362-2334.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2013-08-12
Posted by FDA: 2013-11-14
Terminated: 2014-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122717. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.