Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PIC...
FDA Device Recall #Z-0937-2013 — Class II — December 17, 2012
Recall Summary
| Recall Number | Z-0937-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 17, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vygon Corporation |
| Location | Lansdale, PA |
| Product Type | Devices |
| Quantity | 210 |
Product Description
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
Reason for Recall
Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
Distribution Pattern
Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
Lot / Code Information
Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.
Other Recalls from Vygon Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0113-2015 | Class II | Bionector Needleless connector. Bionector is a ... | Aug 28, 2014 |
| Z-1797-2012 | Class II | Vygon VY(TM)Flush Heparin Lock Flush Syringes, ... | May 11, 2012 |
| Z-1808-2012 | Class II | Churchill Medical Systems, Inc. A VYGON COMPANY... | May 11, 2012 |
| Z-1807-2012 | Class II | Churchill Medical Systems, Inc. DRESSING CHANGE... | May 11, 2012 |
| Z-1802-2012 | Class II | Churchill Medical Systems, Inc. A VYGON Company... | May 11, 2012 |
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.