Safety Enforcement Notice
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Issued for products by Clinical Innovations, LLC
Recall Event Details
- Primary ID / Event Code
- Z-0541-2021
- Classification Code
- Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631
- Manufacturer
- Clinical Innovations, LLC
- Reported Date
- August 9, 2026