Class 2 Device Recall Sterile Empty Vial and Injector (30mL PCA vial),

• Date Initiated by Firm: August 02, 2012
• Date Posted: September 10, 2012
• Recall Status: Terminated on May 08, 2014
• Recall Number: Z-2346-2012
• Recall Event ID: 62909
• 510(K)Number: K043256
• Product Classification: Pump, infusion, pca - Product Code MEA
• Product: 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.
• 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.
• FEI Number: 3013319212
• Recalling Firm/ Manufacturer: Hospira, Inc.; 600 N Field Dr Bldg J45; Lake Forest IL 60045
• For Additional Information Contact: Hospira Customer Care; 877-946-7747
• Manufacturer Reason for Recall: Reports of leaking during filling and administration.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Hospira sent an Urgent Device Field Correction letter dated August 3, 2012, to all affected customers. The letter identifed the product, the probem, and the action to be taken by the customer. Customers were instructed to first consider the use of Prefilled Morphine PCA Vials wherever possible. In some instances, the treating physician may require an alternative to morphine. Customers may continue using the affected product by following the instructions provided in the Correction Letter. Customers were asked to complete the attached Reply Form and fax it to 1-888-879-8144. For questions regarding this recall call 877-946-7747.
• Quantity in Commerce: unknown
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MEA