Rio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
3B Medical, Inc. is recalling Rio II Nasal Pillows Interface devices due to packaging and labeling discrepancies involving product size identification and device identifiers. The affected models are RII1001 (Small), RII1002 (Medium), and RII1003 (Large).
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a packaging and labeling discrepancy with no reported safety hazard, injury, or health risk. FDA Class II recalls involving only labeling or packaging errors without functional safety impact are typically scored as Low to Moderate; this is a cosmetic/documentation issue.
Plain-English summary
3B Medical, Inc. is recalling the Rio II Nasal Pillows Interface, a device intended for use with positive airway pressure therapy devices. The recall involves models RII1001 (Small), RII1002 (Medium), and RII1003 (Large). The issue is a packaging and labeling discrepancy affecting product size identification and the associated Unique Device Identifier (UDI/GTIN).
The affected lots are: RII1001 lots 220121 and 220191; RII1002 lots 220121 and 220191; and RII1003 lots 220121 and 220191. Approximately 375 units were distributed nationwide.
Consumers using an affected Rio II Nasal Pillows Interface should contact 3B Medical, Inc. for guidance on how to proceed. The FDA has classified this as a Class II recall.
The recalled product
- 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…
- Manufacturer
- 3B Medical, Inc.
- Affected units
- 375
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: Affected Catalog Numbers: RII1001
- RII1002
Distribution
Distributed nationwide across the United States.
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