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-1117-2013 · posted 2013-04-15 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 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, Cro
- Date initiated
- 2013-03-21
- Date posted
- 2013-04-15
- Date terminated
- 2016-08-29
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE (K083019) | Hospira, Inc. | 2008-10-22 |
| HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 (K060806) | Hospira, Inc. | 2006-04-21 |