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U.S. Department of Health and Human Services

Class 1 Device Recall GemStar Medical Power Supply

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  Class 1 Device Recall GemStar Medical Power Supply see related information
Date Initiated by Firm February 03, 2014
Date Posted October 24, 2014
Recall Status1 Terminated 3 on March 07, 2017
Recall Number Z-0096-2015
Recall Event ID 68047
510(K)Number K060806  
Product Classification Pump, infusion - Product Code FRN
Product The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
Code Information Desktop GemStar Power Supply List Number: 13072-05; 1) US Distribution Lot Numbers: 10115G1, 11121G1, 11122G1, 1123G1, 11124G1, 12143G1, 12144G1, 12178G1, 15185G1, 12195G1, 17214G1, 18217G1, 18219G1, 19225G1, 20233G1, 21242G1, 22251G1, 23259G1, 24271G1, 25280G1, 26289G1, 26290G1, 27293G1, 27297G1, 27300G1; 2) Foreign Distribution Lot Numbers: 11128G1, 12140G1, 12142G1, 12148G1, 14176G1, 15187G1, 15196G1, 16207G1, 16208G1, 18218G1, 19226G1, 19229G1, 20234G1, 21241G1, 22255G1, 23262G1, 24270G1, 25276G1, 26285G1, 27299G1, 27301G1
Recalling Firm/
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Hospira Global Complaint Management
Manufacturer Reason
for Recall
The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
FDA Determined
Cause 2
Process control
Action An URGENT MEDICAL DEVICE CORRECTION letter dated February 3, 2014 was sent to all direct accounts. The letter included specific instructions for how to handle and use the power supplies so as to minimize the chance of any device failures. There were additional instructions for customers to: 1) Inform potential users in their organization of the product of this notification; 2) Complete the attached reply form and return it to the fax number or e-mail address on the form (even if you do not have any affected product in inventory); 3) If the products were further distributed, their customers should be notified of the recall and asked to contact Stericycle at 888-641-9735 to receive a reply form; and, 4) if a potential user believes that their power supply is damaged for any reason, it should be removed from service and the user should contact Hospira Global Complaints at 800-441-4100 to report the concern. The letter further notes that there is no need to return fully functional power supplies (unless they malfunction).
Quantity in Commerce US Distribution: 4,709 power supplies; Foreign Distribution: 7,425 power supplies
Distribution Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.