Recall Z-1160-2013
Hospira Inc. · initiated March 18, 2013
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: List Numbers: 13086, 13087, 13088
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1160-2013
- Initiated
- March 18, 2013
- Posted by FDA
- April 26, 2013
- Terminated
- March 7, 2017
- Product code
- FRN – Pump, Infusion
- Quantity
- List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps
- Distribution
- 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…
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1159-2013 Class I | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight…Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's… | 03/18/2013Terminated |