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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 Setsee related information
Date Initiated by FirmAugust 12, 2010
Date PostedSeptember 29, 2010
Recall Status1 Terminated 3 on June 21, 2012
Recall NumberZ-2628-2010
Recall Event ID 56505
510(K)NumberK060806 
Product Classification Set, administration, intravascular - Product Code FPA
ProductGemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Yellow Striped Tubing-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 13261-01
Code Information list number 13261-01, lot numbers 691805H, 670695H, 760665H and 772085H 
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information ContactMs. 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
ActionHospira 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 Commerce170,304 sets
DistributionWorldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan.
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.
510(K) Database510(K)s with Product Code = FPA
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