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 from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
USBrand 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 from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
Recalling Firm: 3B Medical, Inc.
Reason for Recall / Hazard
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Product Description & Identification
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 from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
Affected Products
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 from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
Additional Source Details
| Field | Value |
|---|---|
| City | Dublin |
| State | OH |
| Event id | 99247 |
| Address 1 | 5475 Rings Rd Ste 550 |
| Code info | Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191 |
| Postal code | 43017-7537 |
| Report date | 20260722 |
| Product type | Devices |
| Product quantity | 375 |
| Reason for recall | Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20230615 |
| Initial firm notification | Letter |
| Center classification date | 20260715 |
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Overview
- Recalling Firm3B Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.
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🚨 SAFETY ALERT: 3B Medical, Inc. - 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 from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No Check if your household is affected: https://therecallfile.com/recalls/brand-name-rio-ii-product-name-rio-ii-nasal-pillows-interface-model-ca/FDA-Z-2740-2026
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