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. |
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