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U.S. Department of Health and Human Services

Medical Device Recalls

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 Medical Device Recallssee related information
Recall Status1 Open
Recall Number Z-0096-2015
Recall Event ID 68047
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.
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Hospira Global Complaint Management
224-212-2000
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.
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.

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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