Oxygen Concentrator Recall: Rio II Nasal Pillows Interface
Two units of the React Health PHOENIX 5L Oxygen Concentrator from 3B Medical, Inc. were distributed nationwide in the US, including New York, and are recalled because the devices did not meet internal quality specifications. Recall numbers include UDI 06934726614439-250623-MZJ5S713971 (Serial Number MZJ5S713971) and UDI 06934726614439-250623-MZJ5S714009 (Serial Number MZJ5S714009).
| Brand | 3B Medical, Inc. |
|---|---|
| Product | React Health PHOENIX 5L Oxygen Concentrator |
| Reason | Devices which did not meet internal quality specifications were inadvertently distributed. |
| Severity | moderate |
| Units affected | 375 |
| Distribution | US Nationwide distribution in the state of NY. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check if your oxygen concentrator's serial number matches the ones listed.
- Do not use the device until you receive specific recall instructions.
- Contact 3B Medical customer service to verify status and arrange return, replacement, or remedy as directed.
How to identify the recalled item
| Lot / date codes | UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009 |
|---|---|
| Lot / date codes | Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.