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DATE NOTIFICATION INITIATED: October 13, 2005 PRODUCT / LOT NUMBER / EXPIRATION DATE: Transfer Set with 150 micron filter with distal slip lock patient adapter Lot Number: 110220 Catalog Number: 03-960-57 Expiration Date: June, 2009 MANUFACTURER: Charter Medical, Ltd Winston-Salem, NC 27103 REASON: Charter Medical, Ltd. has initiated a voluntary recall of Lot 110220 (Transfer Set with 150 micron filter with distal slip lock patient adapter). The product is labeled sterile. However, the devices were not subjected to ethylene oxide sterilization processing and are therefore, non-sterile. Consignees have been asked to return any affected product to the manufacturer. 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.

Updated November 3, 2005

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