GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product
FDA device recall Z-0421-2015 · posted 2014-11-24 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via website sponsors by downloading the GemStar User/Service Manual featured on the sponsors' websites. The GemStar User/Service Manual should be removed from these w
- Action taken
- Hospira sent a letters dated March 19, 2013 to Internet website sponsors to request removal of the GemStar User/Service Manual from their websites as soon as possible. The Internet website sponsors were requested to return a confirmation form after removing the GemStar User Service Manual from their site. For questions call 224-212-2891.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- Not Applicable
- Distribution
- Worldwide Distribution - US: Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Croatia, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Icelanofd, Ireland, Israel, Ita
- Date initiated
- 2013-03-19
- Date posted
- 2014-11-24
- Date terminated
- 2016-09-09
- 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 |
|---|---|---|
| HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 (K060806) | Hospira, Inc. | 2006-04-21 |