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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

FDA Recall Z-0275-2014 · Posted 2013-11-14

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeHOZ
Date Initiated2013-08-12
Date Terminated2014-08-04
Product Quantity726 cases (7242 units)

Reason for Recall

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

Firm 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 recall call 865-362-2334.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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