Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device. |
|---|---|
| Recall Number | Z-2346-2012 |
| Classification | Class II |
| Code Info | The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter. |
| Product Distributed Qty | unknown |
| Reason For Recall | Reports of leaking during filling and administration. |
Event Detail
| Event Id | 62909 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Hospira, Inc. |
| City | Lake Forest |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-02 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands. |
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