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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

Product Description GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Recall Number Z-1160-2013
Classification Class I
Code Info List Numbers: 13086, 13087, 13088
Product Distributed Qty List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps
Reason For Recall Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.

Event Detail

Event Id 64839
Product Type Devices
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
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