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.
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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