Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF...

FDA Device Recall #Z-0011-2020 — Class II — June 27, 2019

Recall Summary

Recall Number Z-0011-2020
Classification Class II — Moderate risk
Date Initiated June 27, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Inter-Med Llc
Location Racine, WI
Product Type Devices
Quantity 377 units

Product Description

Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700

Reason for Recall

The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.

Distribution Pattern

US, South Africa, Switzerland, Poland, Italy, Singapore, Australia

Lot / Code Information

No UDI Lot/Work Order Numbers: 2018-1192 2018-1473 2018-1742 2018-1999 2018-2386 2018-2741 2019-0047

Other Recalls from Inter-Med Llc

Recall # Classification Product Date
Z-0014-2020 Class II Vista Dental Products Sodium Hypochlorite - 6%,... Jun 27, 2019
Z-0013-2020 Class II Vista Dental Products Sodium Hypochlorite - 3%,... Jun 27, 2019
Z-0015-2020 Class II Vista Dental Products 3% Sodium Hypochlorite, 1... Jun 27, 2019
Z-0012-2020 Class II Vista Dental Products Sodium Hypochlorite - 6%,... Jun 27, 2019
Z-0017-2020 Class II Vista Dental Products Chlor-XTRA - 12mL Prefill... Jun 27, 2019

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.