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DATE NOTIFICATIONS INITIATED: October 18-26, 2004 PRODUCT: Automated Blood Cell Separator, Haemonetics Mobile Collection Systems     MCS+ 9000     MCS+ 7000     MCS+ 8100 Model Numbers     LN 09000-110-E     LN 07000-110-E     LN 08100-110-E MANUFACTURER: Haemonetics Corporation Braintree, Massachusetts REASON: Haemonetics is aware of the possibility when using an MCS machine that a small leak at the base of the Latham bowl may cause the collection of blood from a donor to exceed the recommended extracorporeal volume limit. A bowl base leak causes blood to leak out of the base of the bowl and into the waste bag. Haemonetics began equipping the MCS with a base leak detector starting with serial number 01M185. A Haemonetics service representative will contact consignees. In the meantime, Haemonetics recommends that operators periodically observe the waste bag during a collection procedure. If there are indications of blood products in the waste bag, the procedure should be terminated. 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 December 20, 2004

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