Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co...
FDA Device Recall #Z-2559-2024 — Class II — June 11, 2024
Recall Summary
| Recall Number | Z-2559-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 11, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merit Medical Systems, Inc. |
| Location | South Jordan, UT |
| Product Type | Devices |
| Quantity | 3631 kits |
Product Description
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Catheter Extractor is indicated for use with tunneled, double lumen hemodialysis catheters with cuff sizes ranging from 10.8 French to 14.5 French.
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution Pattern
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Lot / Code Information
Catalog Number: CET200 UDI-DI code: 00884450052587 Lot Numbers: T2651502 T2700122 T2712304 T2748973 T2758209 T2779867 T2833064 T2850758 T2903817 Catalog Number: CET300 UDI-DI code: 00884450045497 T2626011 T2662043 T2701699 T2726893 T2750399 T2758210 T2805965 T2832137 T2849258 T2886083 T2921078
Other Recalls from Merit Medical Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1578-2026 | Class I | DuraMax Chronic Hemodialysis Catheter, REF: H78... | Feb 13, 2026 |
| Z-1576-2026 | Class I | ProGuide Chronic Dialysis Catheters, REF: DC014... | Feb 13, 2026 |
| Z-1577-2026 | Class I | 16F Dual Valved Splittable Sheath Introducer (b... | Feb 13, 2026 |
| Z-1575-2026 | Class I | CentrosFLO Hemodialysis Catheters, REF: CENFP15... | Feb 13, 2026 |
| Z-1579-2026 | Class I | BioFlo DuraMax Catheter, REF: H965103028011/A, ... | Feb 13, 2026 |
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.