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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 Device Recall Empty Evacuated Container 250 mL and 1000 mL.see related information
Date Initiated by FirmAugust 28, 2012
Date PostedSeptember 17, 2012
Recall Status1 Terminated 3 on September 18, 2013
Recall NumberZ-2395-2012
Recall Event ID 63078
Product Classification Container, i.V. - Product Code KPE
ProductEmpty 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 IL 60045-2579
For Additional Information ContactJanet 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		Material/Component Contamination
ActionHospira 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 Commerce191,094 units
DistributionWorldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.
Total Product Life CycleTPLC 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.
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