BEUDAMED
    FDA Recall Terminated

    Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 8881513744

    Recall: Z-0051-2007 · Initiated September 11, 2006

    Recall

    Recall Number
    Z-0051-2007
    Event Number
    36299
    Firm
    Kendall a Division of Tyco Healthcare Group LP
    FEI Number
    1317749
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 11, 2006
    Posted
    October 21, 2006
    Terminated
    September 11, 2009
    Address
    5439 State Route 40, Argyle, NY, 12809-3830

    Description

    Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 8881513744

    Reason

    Incorrect needle: There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.

    Action

    A recall letter was mailed 9/12/2006 to the 44 customers who purchased this product from Tyco Healthcare. The firm requested that their distributors notify their customers, and coordinate recovery of the product. The recall mailing included a form that was to be faxed back to Tyco Healthcare. A postage paid return envelope was also included if the customer does not have access to a fax machine.

    Distribution

    Nationwide

    Quantity

    130,000