Enforcement Report - Week of September 26, 2012
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections. | 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 | Class II | Embedded iron oxide glass defect which may have the potential to break off into the solution. | 191,094 units | Z-2395-2012 |
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