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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Sterile Empty Vial and Injector (30mL PCA vial),
see related information
Date Posted September 10, 2012
Recall Status1 Open
Recall Number Z-2346-2012
Recall Event ID 62909
Premarket Notification
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.
Recalling Firm/
Manufacturer
Hospira, Inc.
600 N Field Dr Bldg J45
Lake Forest, Illinois 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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEA and Original Applicant = HOSPIRA, INC.
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