Z-2346-2012 Class II Terminated
FDA device recall Z-2346-2012 was initiated by Hospira, Inc. on Aug 2, 2012 and is designated Class II. Reason for recall: Reports of leaking during filling and administration. The recall status is terminated (terminated May 8, 2014).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 19, 2012
- Initiation Date
- Aug 2, 2012
- Termination Date
- May 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
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.
Reason for Recall
Reports of leaking during filling and administration.
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2346-2012
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026