Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025,...

FDA Device Recall #Z-0541-2021 — Class II — August 13, 2020

Recall Summary

Recall Number Z-0541-2021
Classification Class II — Moderate risk
Date Initiated August 13, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Clinical Innovations, LLC
Location Murray, UT
Product Type Devices
Quantity 19450 units/kits

Product Description

Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025

Reason for Recall

Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.

Distribution Pattern

US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None

Lot / Code Information

Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631

Other Recalls from Clinical Innovations, LLC

Recall # Classification Product Date
Z-2072-2020 Class II Kiwi Complete Vacuum Delivery System, Model No.... Aug 6, 2019
Z-2118-2020 Class II Clearview Total Uterine Manipulator (model UM75... May 30, 2019
Z-0123-2016 Class II The Ebb Complete Tamponade System, model #CTS-1... Jan 5, 2015
Z-1014-2015 Class II Ebb Complete Tamponade System, BD-OTS Obstetric... Dec 30, 2014

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.