Vaccines, Blood & Biologics

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:
Product NameProduct CodeBatch Number
BMSC9007341YKT162 and XMT127
C4Y (PBSC-LYM-MNC)9007301ZHT262, ZGT153, ZDT021 ZAT251,YLT112, YKT131
P1Y (GRANULO-MNC-BMSC)9007231ZHT181, 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.

Page Last Updated: 08/21/2014
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