Terminated

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.

FDA Recall Z-1159-2013 · Posted 2013-04-26

Recalling FirmHospira Inc.

Recall StatusTerminated

Product CodeFRN

Date Initiated2013-03-18

Date Terminated2017-03-07

Product QuantityList Number 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150: 13,497 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.

Firm Action

Hospira sent an Urgent Device Field Correction letter dated March 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. Lithium batteries that are older than three (3) years should be replaced. Customers should contact their Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, to determine if their battery need to be replaced and if necessary, arrange for the return of their device to perform battery replacement. Customers with questions should call 1-877-907-7516. For questions regarding this recall call 224-212-4892.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083019GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWAREHospira, Inc. · 2008-10-22 K060806HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088Hospira, Inc. · 2006-04-21

Official Source

View FDA Recall →

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