Z-0095-2015 Class I Terminated
FDA device recall Z-0095-2015 was initiated by Hospira Inc. on Feb 3, 2014 and is designated Class I. 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 recall status is terminated (terminated Mar 7, 2017). Affected quantity: 978 power supplies.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 5, 2014
- Initiation Date
- Feb 3, 2014
- Termination Date
- Mar 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 978 power supplies
Product Description
Reason for Recall
Distribution Pattern
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0095-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026