PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer...

FDA Device Recall #Z-2047-2015 — Class III — May 27, 2015

Recall Summary

Recall Number Z-2047-2015
Classification Class III — Low risk
Date Initiated May 27, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bard Access Systems
Location Salt Lake City, UT
Product Type Devices
Quantity N/A

Product Description

PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Reason for Recall

Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

Lot No: REYK1763, Item No. 1194108D

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.