The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospita
FDA device recall Z-1169-2013 · posted 2013-04-30 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- Pump shutting off during use without warning.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- List Number 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150: 13,497 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, Cro
- Date initiated
- 2013-03-18
- Date posted
- 2013-04-30
- Date terminated
- 2017-03-10
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 (K060806) | Hospira, Inc. | 2006-04-21 |