PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged I...
FDA Device Recall #Z-1560-2015 — Class II — March 13, 2015
Recall Summary
| Recall Number | Z-1560-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 13, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Access Systems |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 700 units |
Product Description
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.
Reason for Recall
Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch.
Distribution Pattern
US Distribution to states of: GA and MN.
Lot / Code Information
Lot D430107
Other Recalls from Bard Access Systems
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0985-2017 | Class II | MiniLoc¿ Safety Infusion Set Winged without Y-I... | Dec 19, 2016 |
| Z-0986-2017 | Class II | SafeStep¿ Huber Needle Set with Y-Injection Sit... | Dec 19, 2016 |
| Z-0982-2017 | Class II | StatLock¿ CV Plus w/Pigtail. Product Code: CV02... | Dec 9, 2016 |
| Z-0981-2017 | Class II | StatLock¿ PICC Plus Crescent Foam. Product Code... | Dec 9, 2016 |
| Z-2808-2015 | Class II | Marketing brochures for the PowerPICC and Power... | Jul 20, 2015 |
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.