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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

Product Description Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Recall Number Z-2395-2012
Classification Class II
Code Info 250 mL size - Lot 11179DW, Exp, Date 1NOV2013, 11195DW, Exp. Date 1NOV2013 and 93854DW, Exp. Date 1SEP2012 - 1000 mL size - Lot 92835DW, Exp. Date 1AUG2012, Lot 96090DW, Exp. Date 1DEC2012, and Lot 96098DW, Exp. Date 1DEC2012
Product Distributed Qty 191,094 units
Reason For Recall Embedded iron oxide glass defect which may have the potential to break off into the solution.

Event Detail

Event Id 63078
Product Type Devices
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.