—#117159

Product

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. 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.

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

Why it was recalled

Pump shutting off during use without warning.

Root cause (FDA determination)

Device Design

Action the firm took

Hospira sent an Important Device Information letter dated March 18, 2013, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect the affected product for signs of leakage, corrosion or other damage prior to each use. In addition, each time the batteries are replaced the battery compartment should be inspected for damage. If a device exhibits damage caused by leakage, it should immediately be removed from clinical service and Hospira should be contacted at 1-800-441-4100 to arrange for return of the device for repair. If the product has been further distributed they should notify their consignees and confirm they have done so by returning the reply form to Stericycle. 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) and internationally to 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: 2013-04-30
Terminated: 2017-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117159. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.