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Hospira Inc. recalls GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150.
Recalled July 16, 2014 · FDA recall Z-2031-2014 · Hospira
Hazard
The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service. · FDA Class II
Units
36,881 infusion pumps
Sold at
Worldwide Distribution - US: Nationwide in the state 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, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY including District Of Columbia, Guam, Puerto Rico; and the countries of Austria, Australia, Bahrain, Belgium, Canada, Chile, France, Germany, Greece, Guatemala, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Netherlands, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela
Description
The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
Product
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.
Manufacturer(s)
Hospira Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →