3B Medical, Inc.: Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) So…
Hazard
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Details
Distribution: US Nationwide distribution.. Recall #Z-2740-2026, initiated 20230615. Voluntary: Firm initiated.
Products affected
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow f…
Recall status
Ongoing