—#117160

Product

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 product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K060806, K083019
Affected lot / code info: List Numbers: 13000, 13100, 13150

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

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.

Timeline

Recall initiated: 2013-03-18
Posted by FDA: 2013-04-26
Terminated: 2017-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117160. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.