BEUDAMED
    FDA Enforcement Class II Terminated

    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.

    Recall: Z-1746-2017 · Reported April 12, 2017

    Enforcement

    Recall Number
    Z-1746-2017
    Event ID
    76826
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 12, 2017
    Initiation Date
    March 16, 2017
    Classification Date
    April 6, 2017
    Termination Date
    May 1, 2018
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.

    Reason

    BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.

    Code Info

    Catalog Number: 367716 - Lot numbers: 5251673 with expiry 3/31/2017; 6064542 with expiry 9/30/17; 6187520 with expiry 1/31/2018 and 6253669 with expiy 3/31/18 Catalog Number: 369714 - Lot numbers: 5272777 with expiry 4/30/17; 5336909 with expiry 6/30/17; 5357632 with expiry 7/31/17; 6040953 and 6064634 both with expiry 9/30/17; 6090572 with expiry 10/31/17; 6124932 with expiry 11/30/17; 6173983 with expiry 12/31/17; 6187600 with expiry 1/31/18 and 6216656 with expiry 2/28/18 Lot numbers 6064542, 6187520 and 6253669 - limited to distribution outside the U.S. market. UDI for lot 6253669 is DI (01)30382903677161, PI (17)180331(10)6253669(30)0100 and lot 6216656 is DI (01)30382903697145, PI (17)180228(10)6216656(30)0100; for all other lots UDI is not applicable based on manufacture date.

    Distribution

    Worldwide - US Nationwide Distribution

    Quantity

    13,064,500 tubes (non-expired)