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U.S. Department of Health and Human Services

Class 2 Device Recall Gemstar Pump Set

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  Class 2 Device Recall Gemstar Pump Set see related information
Date Initiated by Firm August 12, 2010
Date Posting Updated September 29, 2010
Recall Status1 Terminated 3 on June 21, 2012
Recall Number Z-2632-2010
Recall Event ID 56505
510(K)Number K060806  
Product Classification Set, administration, intravascular - Product Code FPA
Product Gemstar Pump Set, LifeShield Latex-Free Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, 3 inch Segment of Clear PVC Tubing, 0.2 Micron Filter, Clave Port-SL, Attached Pressure-Activated Anti-Siphon Valve, Nonvented, 96 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 20634-01
Code Information list number 20634-01, lot number 682085H

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Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Ms. Ileana Quinones
224-212-2000
Manufacturer Reason
for Recall
Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication..
FDA Determined
Cause 2
Nonconforming Material/Component
Action Hospira issued Urgent Device Recall letters dated August 12, 2010 to Hospira's direct accounts, informing them of the potential for under delivery under low rate settings using the affected lots of pump sets. The accounts were instructed to examine their inventory for the affected product, quarantine it immediately, and complete the attached reply form indicating the amount of product being returned, faxing it to Stericycle at 1-877-523-9110. If they distributed the affected product further, they were instructed to sub-recall the product from their sub-accounts. Accounts may contact Hospira Customer Care at 1-877-946-7747 or their Hospira Account Manager to obtain replacement product. For medical inquiries, the accounts were directed to contact Hospira Medical Communications at 1-800-615-0187. Customers may contact Stericycle, which is managing this recall, at 877-274-7163 for further information concerning this recall.
Quantity in Commerce 4,800 sets
Distribution Worldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan.
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 = FPA and Original Applicant = HOSPIRA, INC.
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