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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira GemStar Docking Station

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 Class 2 Recall
Hospira GemStar Docking Station
see related information
Date Posted August 31, 2011
Recall Status1 Open
Recall Number Z-3107-2011
Recall Event ID 59470
Premarket Notification
510(K) Number
K042980 
Product Classification Pump, Infusion - Product Code FRN
Product 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.
Code Information List Number 13075-04-01, batch numbers 15047G1, 15048G1, 15050G1, 17100G1, 19140G1, 19142G1, 19157G1, 20165G1, 20180G1, 21183G1, 21196G1, 21197G1, 62001L2, 63001L2, 68002L2, 69002L2, 73002L2 and 78001L2; List Number 13075-04-03, batch numbers 26289G1, 27314G1, 27324G1, 30375G1, 34499G1, 34601G1, 34603G1, 34605G1, 34606G1, 34608G1, 35615G1, 40764G1, 40765G1, 40766G1 and 41804G1; List Number 13075-04-05, batch numbers 41802G1, 44848G1, 44854G1, 45879G1, 45879G101, 45879G1R, 45884G1, 46910G1, 47916G1, 47936G1, 48960G1, 51031G1, 51032G1, 60285G1, 84824G1, 84827G1, 84831G1 and 85844G1; List number 13075-04-07, batch numbers 75679G1, 7698G1, 77698G101, 77715G1, 77715G101, 78734G1, 80774G1, 81784G1, 82789G1 and 87880G1; List number 13075-24-01, batch numbers 10899G1, 10910G1, 10917G1, 10930G1, 14010G1, 15046G1, 16060G1, 19141G1, 19144G1, 19145G1, 19146G1, 19147G1, 19148G1, 19149G1, 20171G1, 21191G1, 21203G1, 26289G1, 64001L2, 68001L2, 69001L2, 71001L2 and 73001L2; List number 13075-24-03, batch numbers 26289G1, 26294G1, 27325G1, 31397G1, 35620G1, 35621G1, 36634G1, 36636G1, 36638G1, 37667G1, 39739G1, 41786G1, 54114G1, 74001L2, 78002L2, 80001L2, 82001L2, 85308G1, 86319G1, 87340G1, 88358G1, 88366G1, 90442G1 and 92486G1; List number 13075-24-05, batch numbers 19141G1, 45878G1, 47915G1, 48961G1, 50020G1, 51021G1, 51022G1, 51028G1, 51030G1, 53081G1, 53082G1, 54098G1, 54113G1, 54114G1, 55125G1, 55126G1, 55135G1, 56158G1, 56170G1, 59230G1, 59231G1, 60258G1, 60272G1, 60284G1, 61307G1, 63318G1, 64345G1, 64354G1, 73634G1, 73636G1, 74647G1, 84828G1, 84828G1R, 84830G1 and 84830G1R; List number 130752407, batch numbers 75680G1, 75681G1, 75682G1, 76686G1, 77694G1, 77694G1R, 77695G1, 77695G1R, 77696G1, 77697G1, 77712G1, 77712G1R, 77713G1, 77714G1, 78735G1, 78735G1R, 78736G1, 78736G1R, 78737G1, 80775G1, 80775G1R, 82799G1, 82799G1R, 82802G1, 82802G1R, 93962G1, 93962G1R, 94973G1, 94973G1R, 95981G1, 95981G1R, 95985G1, 95985G1R, 96004G1, 96004G1R, 96989G1, 96989G1R, 96996G1, 96996G1R, 97013G1, 97013G1R, 97017G1 and 97017G1R
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Ms. Ileana Quinones
224-212-2000
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action 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. ***.
Quantity in Commerce 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, Singapore, Spain, Sweden and Switzerland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.
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