StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit wit...
FDA Device Recall #Z-0981-2017 — Class II — December 9, 2016
Recall Summary
| Recall Number | Z-0981-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 9, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bard Access Systems |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 30,000 units total |
Product Description
StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock¿ PICC Plus and StatLock¿ CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
Reason for Recall
Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
Distribution Pattern
Worldwide Distribution - US Nationwide
Lot / Code Information
Lot Number: JUZGF345 & JUAQF020
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-2808-2015 | Class II | Marketing brochures for the PowerPICC and Power... | Jul 20, 2015 |
| Z-2049-2015 | Class III | PowerPICC SOLO Catheter with Tip Location Syste... | May 27, 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.