Recall Z-0567-2010

Reason for recall

Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the unit to sound an alarm and shut down. If the patient does not have access to an alternate supply of oxygen or access to AC or DC power, this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences.

FDA-determined cause: Pending

Action taken

The recall notification was initiated on November 12, 2009 with the firm forwarding a "Medical Device Correction" letter to all of the affected consignees via US Postal Service for US Consignees and FedEx for Foreign Consignees. The Medical Device Correction Letter contained the following: (1) Medical Device Correction Letter; (2) List of Serial Number affected that were distributed to the Provider; (3) Reply Card that the Provider will be requested to send back regarding receipt notification of the Medical Device Correction Letter and confirming that they have the affected product; (4) Additional Medical Device Correction Letters for Providers to distribute to their patients. The Medical Device Correction Letter informed the consignees of the reason for recall, the hazard involved and the actions that were required. For further details or information, consignees were instructed to contact SeQual Technical Support at 1-800-826-4610 from 8:00 AM to 5:00 PM PST.