ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous...

FDA Device Recall #Z-2352-2015 — Class II — June 29, 2015

Recall Summary

Recall Number Z-2352-2015
Classification Class II — Moderate risk
Date Initiated June 29, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Merit Medical Systems, Inc.
Location South Jordan, UT
Product Type Devices
Quantity 950

Product Description

ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.

Reason for Recall

Merit Medical Systems, Inc. is voluntarily conducting a recall due to a potential discrepancy between the unit labeling of the Merit ReSolve Drainage Catheters and the actual device in the package.

Distribution Pattern

Nationwide Distribution including the Virgin Islands.

Lot / Code Information

Lot No: E796578 E796579 MR792035 MR786325 MR797946 MR791206 MR791212 MR786923 E796605 MR786311 MR791660 E796647 RL MR795466 MR786301 E796629 E796631 E796636 E796637 MR786306 MR786320 MR786318 MR786319

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.