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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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
 

MANUFACTURER:
Fresenius Kabi , LLC
Redmond, Washington
REASON:
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.