InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. P...

FDA Device Recall #Z-0676-2016 — Class II — January 5, 2016

Recall Summary

Recall Number Z-0676-2016
Classification Class II — Moderate risk
Date Initiated January 5, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Rymed Technologies, LLC
Location Austin, TX
Product Type Devices
Quantity 46,600 units

Product Description

InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

Reason for Recall

Potential for the female luer component of the InVision-Plus IV connector to crack during use.

Distribution Pattern

US Nationwide Distribution.

Lot / Code Information

Catalog number RYM-7001 Lots: R01842, R01889, R01891, and R01897, Expire 03/2016.

Other Recalls from Rymed Technologies, LLC

Recall # Classification Product Date
Z-0675-2016 Class II InVision-Plus and InVision-Plus Junior Needlele... Jan 5, 2016

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.