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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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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
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II Reports of leaking during filling and administration. unknown Z-2346-2012