GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar acces...
FDA Device Recall #Z-1512-2014 — Class I — February 18, 2014
Recall Summary
| Recall Number | Z-1512-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | February 18, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hospira Inc. |
| Location | Lake Forest, IL |
| Product Type | Devices |
| Quantity | 26,765 docking stations total (6866 in US) |
Product Description
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
Reason for Recall
There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a GemStar Phase 3 (List 13000-XX, 13100-XX, or 13150-XX)or GemStar Phase 4 pump (List 13086-XX, 13087-XX, or 13088-XX) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX) there exists a possibility that the GemStar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm.
Distribution Pattern
Worldwide Distribution - USA including 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, District of Columbia, Guam, Puerto Rico, and Internationally to Australia, Austria, Bahrain, Belgium, Canada, Chile, Egypt, France, Germany, Greece, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxemburg, Netherlands, New Zealand, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
Lot / Code Information
*** US DOCKING STATIONS *** List Numbers: 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-04-09. *** FOREIGN DOCKING STATIONS *** List Numbers: 13075-24-01, 13075-24-03, 13075-24-05, 13075-24-07, 13075-92-09.
Other Recalls from Hospira Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1832-2016 | Class II | The Plum 360 is a large volume infuser capable ... | Mar 25, 2016 |
| Z-1833-2016 | Class II | The Plum A+ is a dual-line volumetric infusion ... | Mar 25, 2016 |
| Z-0863-2016 | Class II | The Symbiq infusion pump is a device used in a ... | Dec 22, 2015 |
| Z-1074-2015 | Class I | The Plum A+ Infusion System is designed to meet... | Jul 2, 2014 |
| Z-1073-2015 | Class I | The Plum A+ Infusion System is designed to meet... | Jul 2, 2014 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.