BEUDAMED
    FDA Recall Terminated

    BacT/ALERT Blood Collection Adapter The BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of blood into the BacT/alert Blood Culture Bottle when using a butterfly blood collection set.

    Recall: Z-1336-2012 · Initiated March 5, 2012

    Recall

    Recall Number
    Z-1336-2012
    Event Number
    61362
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    GIM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 5, 2012
    Posted
    March 30, 2012
    Terminated
    September 4, 2014
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    BacT/ALERT Blood Collection Adapter The BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of blood into the BacT/alert Blood Culture Bottle when using a butterfly blood collection set.

    Reason

    The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer Safety Lok Blood Collection Set. The incompatibility is the blood collection set needle backing out of the adapter cap that results in an exposed sheathed needle that may lead to an accidental needlestick.

    Action

    bioMerieux sent an Urgent Product Correction Notice letter dated March 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: 1. Ensure the letter and guidance on how to maintain control of the luer connector by securing it between the thumb and forefinger are distributed to all appropriate personnel within their organization. 2. Fill out and return the Acknowledgement Form by Fax to confirm receipt of the recall notice. For additional assistance or questions customers were instructed to contact their local bioMerieux Customer Service Representative at (800) 682-2666, option 3, then option 3 again. Industry customers should call 800- 634-7656, option 3. For questions regarding this recall call 314-731-8537.

    Distribution

    Worldwide Distribution - USA (nationwide), Australia, Brazil, Canada, Chile, Columbia, Costa Rica, France, China, Indonesia, Korea, Mexico, Peru, Singapore, Ecuador, Dominican Republic, Philippines, Guatemala, Curacao, Thailand, United Arab Emirates, Andorra, Austria, Burkina Faso, Congo, Switzerland, Cameroon, Germany, Algeria, Estonia, Spain, France, Great Britain, French Guiana, Croatia, Israel, India, Italy, Kazakhstan, Lithuania, Latvia, Macedonia, Malta, New Caledonia, Netherlands, French Polynesia, Poland, Portugal, Reunion, Russia, Sweden, Slovenia, Chad, Turkey, South Africa, Saudi Arabia, Congo, Cote DIvoire, Denmark, Djibouti, Finland, Greece, Guadeloupe, Libyan Arab Jamahiriya, Jordan, Morocco, Martinique, Norway, Senegal, Togo, Yemen, Bangladesh, Georgia, Ghana, Uganda, and Qatar.

    Quantity

    274,800 boxes (32,862,600 caps)