BEUDAMED
    FDA Recall Terminated

    Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).

    Recall: Z-0615-2011 · Initiated November 4, 2010

    Recall

    Recall Number
    Z-0615-2011
    Event Number
    57214
    Firm
    Endocare, Division Of Healthtronics
    FEI Number
    3008262715
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 4, 2010
    Posted
    December 13, 2010
    Terminated
    April 14, 2011
    Address
    9825 Spectrum Dr, Bldg 2 # 275, Austin, TX, 78717

    Description

    Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).

    Reason

    Mislabeled : The label on the outer box and inner pouch of the EndoCare 2.4mm CryoProbe (CRYO-44F) inaccurately reference the CVA2400 (2.4mm Variable Probe aka: V-Probe).

    Action

    Healthronics issued an Urgent Device Recall letter dated November 2, 2010 to consignees. The letter described the product mislabeling, and requested customers to examine their inventory, quarantine all affected product, and complete and return the verfication section of the letter to the firm. A return authorization number and prepaid return label were provide to facilitate return and replacement. Healthronics can be contacted at 877 367-4873 concerning this recall.

    Distribution

    Nationwide Distribution: to the states of FL, MI, PA, TN, and WA.

    Quantity

    33 Units