HME Alert: Recall Issued for OxyTOTE Portable Oxygen Unit
CHAP was recently notified of a Class I recall of the OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company and wanted to share that information with our customers.
Western/Scott Fetzer has received reports of incidents in which the device has malfunctioned, including one injury and one death. When the injury occurred, the unit was dropped from 4 feet; where the death occurred, the employee did not drop the gas cylinder, but set it down by his side.
The company is recommending that users and providers:
- Locate and identify any OxyTOTE/oxyQuik/AirTOTE product in your possession.
- Review the instructions to determine if the product IS or IS NOT marked and if remediation is needed.
- Contact your OxyTOTE/oxyQuik/AirTOTE supplier or Medical Gas Provider directly to schedule the remediation of product in your possession.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Read the MedWatch Safety Alert, including a link to the FDA Recall Notice here.