BEUDAMED
    FDA Recall Terminated

    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

    Recall: Z-0756-2013 · Initiated November 12, 2012

    Recall

    Recall Number
    Z-0756-2013
    Event Number
    64010
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 12, 2012
    Terminated
    September 6, 2013
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

    Reason

    BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.

    Action

    BD sent "ATTENTION: PRODUCT RECALL" letters dated November 12, 2012 via UPS to distributors and customers instructing them to examine their inventory immediately and discontinue the shipment of the affected product. All customers were instructed to return all products from the lot affected, by following the instructions on the enclosed packing slip,and BD will send them replacement products at no charge. Contact the firm at 10201-847-4267 for assistance.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.

    Quantity

    2,944,700 units