Urgent Device Recall - Bone Marrow Collection Bag (BMSC), C4Y and P1Y Procedure Sets (used on the AS104 Blood Cell Separation Device)
DATE RECALL INITIATED:
March 23, 2011
PRODUCT NAME/ PRODUCT CODE/ BATCH NUMBER:
|Product Name||Product Code||Batch Number|
|BMSC||9007341||YKT162 and XMT127|
|C4Y (PBSC-LYM-MNC)||9007301||ZHT262, ZGT153, ZDT021 ZAT251,YLT112, YKT131|
|P1Y (GRANULO-MNC-BMSC)||9007231||ZHT181, ZAT281, YET062 YCT061, XLT062, XFT112|
Fresenius Kabi , LLC
A recent review of Fresenius Kabi’s original submission documents for the above mentioned sets revealed that the application for their use in the US was never approved by the FDA. As a result, these sets are not in compliance with FDA regulations or registrations. Customers are asked to immediately discontinue distributing or dispensing the affected products and to return all units to Fresenius Kabi, LLC.
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.