BEUDAMED
    FDA Recall 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 · Initiated August 12, 2013

    Recall

    Recall Number
    Z-0275-2014
    Event Number
    66608
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    HOZ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 12, 2013
    Posted
    November 14, 2013
    Terminated
    August 4, 2014
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    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.

    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.

    Distribution

    Nationwide Distribution

    Quantity

    726 cases (7242 units)