FDAHealthJune 15, 2023
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 Descript
⚠️ Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 15, 2023
US Nationwide distribution.
What's affected?
- Product
- 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
- Brand
- 3B Medical, Inc.
- Lot code
- Affected
Additional details
Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 375.
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