FDAFDA · Food and drugs·Recall number Z-2346-2012
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.
Published September 19, 2012 · Recall initiated: August 2, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of leaking during filling and administration.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hospira, Inc.
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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