Gemstar Pump Set-SL, Latex-Free Set with Attached Pressure-Activated Anti-Siphon Valve, Nonvented, 96 inch; Rx, sterile,

FDA device recall Z-2630-2010 · posted 2010-09-29 · Terminated

Recall details

Recalling firm

Hospira Inc.

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.

Action taken

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

Status

Terminated

Product code

FPA

Quantity affected

65,832 sets

Distribution

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

Date initiated

2010-08-12

Date posted

2010-09-29

Date terminated

2012-06-21

Location

Lake Forest, IL

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