Recall Z-1117-2013
Hospira Inc. · initiated March 21, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: List Numbers: 13086, 13087, 13088
Reason for recall
During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
FDA-determined cause: Nonconforming Material/Component
Action taken
Hospira sent an Urgent Device Field Correction letter dated March 21, 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 refrain from using the affected produc and contact Hospira at 1-800-441-4100 to arrange for return of their device for repair. Customers were directed to notify their customers if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. For questions regarding this recall call 224-212-4892.
Details
- Recall number
- Z-1117-2013
- Initiated
- March 21, 2013
- Posted by FDA
- April 15, 2013
- Terminated
- August 29, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 1) List Number 13086: 286 pumps; 3) List Number 13087: 45,376 pumps; 4) List Number 13088: 23,492 pumps
- Distribution
- 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…
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1116-2013 Class II | The GemStar Pump is a small and lightweight, single channel infusion device designed for…During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication… | 03/21/2013Terminated |