Class 2 Device Recall Gemstar Pump Set

• Date Initiated by Firm: August 12, 2010
• Date Posted: September 29, 2010
• Recall Status: Terminated on June 21, 2012
• Recall Number: Z-2627-2010
• Recall Event ID: 56505
• 510(K)Number: K060806
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve and Y-Extension with Backcheck Valve-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 12640-01
• Code Information: list number 12640-01, lot numbers 682105H and 770815H
• 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: 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: 22,680 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.