3b Medical, Inc.: Ventilator, Non-continuous (respirator)
Recall Summary 3B Medical is recalling Rio II nasal pillows interfaces (models RII1001, RII1002, and RII1003) distributed nationwide because the packaging and labels have errors in the product size identification and device identifier codes. These nasal pillows are attachments used with positive airway pressure therapy devices to deliver air to the patient's nose. The issue involves labeling discrepancies rather than a safety defect with the device itself.
- Recalling firm
- 3B Medical, Inc.
- 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
- Reason
- Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2023-06-15
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f574096c-f805-4470-b288-f4cdca13d202