PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 c...
FDA Device Recall #Z-0033-2015 — Class II — August 25, 2014
Recall Summary
| Recall Number | Z-0033-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 25, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Navilyst Medical, Inc |
| Location | Glens Falls, NY |
| Product Type | Devices |
| Quantity | 60 units/pouches |
Product Description
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Reason for Recall
NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Distribution Pattern
Nationwide Distribution
Lot / Code Information
Batch/Lot No. 4754052 (exp. 30-Apr-15)
Other Recalls from Navilyst Medical, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1164-2015 | Class II | NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600... | Jan 9, 2015 |
| Z-1207-2015 | Class II | NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496... | Jan 9, 2015 |
| Z-1167-2015 | Class II | NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496... | Jan 9, 2015 |
| Z-1176-2015 | Class II | NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496... | Jan 9, 2015 |
| Z-1184-2015 | Class II | NAMIC Convenience Kit, UPN H749601904231, REF/C... | Jan 9, 2015 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.