Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro M...
FDA Device Recall #Z-1704-2014 — Class II — January 24, 2014
Recall Summary
| Recall Number | Z-1704-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 24, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hospira Inc. |
| Location | Lake Forest, IL |
| Product Type | Devices |
| Quantity | List Number 11781: 1,828 pumps; List Number 11845: 13,700 pumps; List Number 11846: 22,671 pumps |
Product Description
Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
Reason for Recall
There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion
Distribution Pattern
Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.
Lot / Code Information
List Number: 11781; Serial Numbers: All. List Number: 11845; Serial Numbers: All. List Number: 11846; Serial Numbers: All.
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 healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.