DATE NOTIFICATION INITIATED:
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
Charter Medical, Ltd
Winston-Salem, NC 27103
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.