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Medical Device Notification
150mL Eight Bag Aliquot System with Piercing Pin and Needleless Syringe Adaptor

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DATE NOTIFICATION INITIATED:

    June 10, 2005 - Distributor Notification
    June 20, 2005 - Customer Notification

PRODUCT / LOT NUMBER:

    150mL Eight Bag Aliquot System with Piercing Pin and Needleless Syringe Adaptor

    Lot Number: 108779
    Catalog Number: T2288

MANUFACTURER:

    Charter Medical, Ltd. Winston-Salem, North Carolina

REASON:

    Charter Medical, Ltd. has initiated a voluntary recall of transfer packs, lot 108779. The product label is missing relevant information including sterilization method, expiration date, "Rx only" symbol and the "Do Not Reuse" symbol. Consignees have been asked to contact the manufacturer to arrange for an on-site visit to correct the labeling.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

 
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