GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospi

FDA device recall Z-3107-2011 · posted 2011-08-31 · Terminated

Recall details

Recalling firm

Hospira Inc.

Reason for recall

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.

Action taken

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. ***

Root cause

Device Design

Status

Terminated

Product code

FRN

Quantity affected

18,000 units

Distribution

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, Sing

Date initiated

2011-08-01

Date posted

2011-08-31

Date terminated

2016-08-29

Location

Lake Forest, IL

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