BEUDAMED
    FDA Recall Terminated

    Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK

    Recall: Z-1954-2010 · Initiated May 24, 2010

    Recall

    Recall Number
    Z-1954-2010
    Event Number
    55894
    Firm
    Medrad Inc
    FEI Number
    3006316319
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 24, 2010
    Posted
    July 9, 2010
    Terminated
    October 13, 2010
    Address
    100 Global View Dr, Warrendale, PA, 15086

    Description

    Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK

    Reason

    Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury.

    Action

    The recalling firm issued an Urgent Medical Device Field Correction on 5/24/10 requesting customers to check their inventory for the affected lots and complete the fax back form with the amount of product in stock. The manufacturer plans to make arrangements to provide individually packaged low-pressure connector tubing to use with the product in the event that cracking or breaking and leaking of the T connector is observed. This requires vigilance by the customers over the life of all of the devices. For questions concerning this recall, please contact the company 1-800-633-7231, select option 2, and indicate that you are calling about the Stellant CT Dual Syringe Kit field correction.

    Distribution

    nationwide and Worldwide distribution includes AU, BE, BG, BM, BR, CA, CH, CI, CL, CN, CO, CS, DE, DK, EC, EG, FI, FR, GB, GT, HN, IN, IT, JM, JP, KW, KY, MU, MX, MY, NL, OM, PA, PH, PK, PR, SE, SG, TW, YE, ZA.

    Quantity

    1,382,889 kits