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U.S. Department of Health and Human Services

Class 2 Device Recall Empty Evacuated Container 250 mL and 1000 mL.

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 Class 2 Recall
Empty Evacuated Container 250 mL and 1000 mL.
see related information
Date Posted September 17, 2012
Recall Status1 Terminated on September 18, 2013
Recall Number Z-2395-2012
Recall Event ID 63078
Product Classification Container, I.V. - Product Code KPE
Product Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Code Information 250 mL size - Lot 11179DW, Exp, Date 1NOV2013, 11195DW, Exp. Date 1NOV2013 and 93854DW, Exp. Date 1SEP2012 - 1000 mL size - Lot 92835DW, Exp. Date 1AUG2012, Lot 96090DW, Exp. Date 1DEC2012, and Lot 96098DW, Exp. Date 1DEC2012
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Janet Stevens
224-212-2000
Manufacturer Reason
for Recall
Embedded iron oxide glass defect which may have the potential to break off into the solution.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action Hospira sent an "URGENT DEVICE RECALL" dated August 28, 2012 to all affected customers. The letter identified the product, problem,and actions to be taken by the customers. The letter included an Urgent Device Recall Reply Form for customers to complete and return via fax to 1-888-237-5582. Contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.
Quantity in Commerce 191,094 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.
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.
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