BEUDAMED
    FDA Recall Terminated

    Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use

    Recall: Z-0035-2011 · Initiated September 2, 2010

    Recall

    Recall Number
    Z-0035-2011
    Event Number
    56685
    Firm
    Excelsior Medical Corp
    FEI Number
    1000122362
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 2, 2010
    Posted
    October 20, 2010
    Terminated
    August 23, 2012
    Address
    1933 Heck Ave, Neptune, NJ, 07753

    Description

    Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use

    Reason

    There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility

    Action

    Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 2, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue using syringes from the listed lots and return the attached Customer Reply Form via fax (866) 688-3185 as confirmation that notification had been received and that proper arrangements can be made to have the product returned to the firm. The customers were also instructed to inform their customers, if they have resold products, of the recall and instruct them to return the form, and verify that they have returned all unused syringes from any of the listed lots . NOTE: The customers were informed that they may alternatively have the products destroyed and certified to Excelsior that they have done so. They must include a copy of the certificate of destruction with the attached Customer Reply Form via fax. - Excelsior issued a press release on October 14, 2010. The press release advised consumers of the recall and requested that use of the product be immediately discontinued and returned to the point of purchase. Should you have any questions regarding the recalled product, please contact Excelsior Medical Customer Service at (800) 487-4276 or if you prefer by fax (866) 688-3185. You may also contact us at [email protected].

    Distribution

    Worldwide distribution: USA and countries including Canada and Brazil.

    Quantity

    13,734,640