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U.S. Department of Health and Human Services

Class 2 Device Recall GemStar Bolus Cord

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 Class 2 Recall
GemStar Bolus Cord
see related information
Date Posted April 26, 2012
Recall Status1 Open
Recall Number Z-1463-2012
Recall Event ID 61472
Premarket Notification
510(K) Numbers
K023062  K042980  K051079  K060806  K083019 
Product Classification Pump, Infusion - Product Code FRN
Product GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027; An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician up to 6 feet (1.8 m) away from the pump.
Code Information List Number 13027, all units
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
Manufacturer Reason
for Recall
Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Hospira, sent an "URGENT DEVICE FIELD CORRECTION RECALL" letter dated March 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to take care when removing the bolus cord from the base of the GemStar unit, inspect the cord for damage, discontinue using any damaged cords, and to call Hospira at 1-800-241-4002 for replacement. A Reply Form was enclosed for customers to complete and return via fax to 1-866-912-7085 or e-mail to: Hospira2627@stericycle.com. Contact Hospira Customer Care at 1-877-946-7747 for technical assistance.
Quantity in Commerce 47,127 cords - U.S. and 39,968 cords - ROW
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nola, Norway, Oman, Philippines, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay and Venezuela.
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 = ABBOTT LABORATORIES INC
510(K)s with Product Code = FRN and Original Applicant = HOSPICARE, INC.
510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.
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