LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-admin...
FDA Device Recall #Z-2874-2016 — Class II — March 8, 2013
Recall Summary
| Recall Number | Z-2874-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 8, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hospira Inc. |
| Location | Lake Forest, IL |
| Product Type | Devices |
| Quantity | 69 |
Product Description
LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Reason for Recall
Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.
Distribution Pattern
United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
Lot / Code Information
Serial Number 12921204 12922976 12924008 12925861 12925924 12925998 12928528 12928807 12929016 12929126 12920432 12920820 12920856 12920915 12921404 12921413 12922304 12922976 12925861 12925998 12927215 12929016 12931044 12931141 12931155 12931192 12931244 12931342 12931361 12931413 12931610 12931639 12931649 12931911 12921480 12921487 12923723 12924326 12924350 12924546 12925259 12925447 12926315 12927938 12928075 12928614 12930418 12930709 12930890 12931441 12931760 12931911 12932487 12932717 12920754 12920791 12920897 12921063 12921613 12922062 12923441 12924161 12926859 12927756 12928775 12929346 12929438 12931942 12920112
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.