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Terminated

Gemstar Pump Set-SL, Latex-Free Extension Set with Integral 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 13263-01

FDA Recall Z-2629-2010 · Posted 2010-09-29

Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2010-08-12
Date Terminated2012-06-21
Product Quantity6,096 sets

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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