GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; List Numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-24-01, 13075-24-03, 13075-24-05 and 13075-24-07, Note: list numbers with xxxxx-04-xx are for U.S., Canada, Japan, Netherlands and Singapore, while those with xxxxx-24-xx are for international distribution only. The docking station for the GemStar pump is used to provide an alternate power source, acting either as a direct current battery backup, or as an alternating current power source when the docking station is plugged into AC power. The docking station also serves as a stand in which to place the GemStar during pump operation.
Recall
- Recall Number
- Z-3107-2011
- Event Number
- 59470
- Firm
- Hospira Inc.
- FEI Number
- 3013319212
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 1, 2011
- Posted
- August 31, 2011
- Terminated
- August 29, 2016
- Address
- 275 N Field Dr, Lake Forest, IL, 60045-2579
Description
GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; List Numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-24-01, 13075-24-03, 13075-24-05 and 13075-24-07, Note: list numbers with xxxxx-04-xx are for U.S., Canada, Japan, Netherlands and Singapore, while those with xxxxx-24-xx are for international distribution only. The docking station for the GemStar pump is used to provide an alternate power source, acting either as a direct current battery backup, or as an alternating current power source when the docking station is plugged into AC power. The docking station also serves as a stand in which to place the GemStar during pump operation.
Hospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar Docking Station due to fluid ingress into the docking station.
Hospira Inc. sent an "URGENT DEVICE FIELD CORRECTION" letter dated August 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The requests that customers do not hang or place fluid containers over the docking station, not spray fluid directly on the docking station, and to clean the docking station using a cloth dampened with an apporoved cleaning solution. A reply form was attached to the letter for customers to complete and return via fax at 262-577-6921. Contact Hospira at 1-800-441-4100 for questions concerning this notice. *** Hospira sent an update letter dated September 26, 2012 to the accounts, informing them of the availability of the improved design replacement docking stations, and requesting them to complete and return the enclosed reply via fax or e-mail to Hospira, indicating the number of docking stations to be returned for replacement at no charge if the old docking stations are returned within 45 days of receipt of the replacement stations. ***
Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Japan, Jordan, the Netherlands, Portugal, Saudi Arabia, Singapore, Spain, Sweden and Switzerland.
18,000 units