Recall Z-1474-2008 ยท CAW Generator, Oxygen, Portable
Medline Industries Inc
Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS021; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.
| Date | Jul 23, 2008 (initiated Mar 4, 2008) |
| Status | Terminated |
| Reason | Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional. |
| Root cause | Device Design |
| Action | Consignees were notified by a letter sent on 3/4/08. The letter informed users that the recalling firm will replace the affected units with new units or issue a credit for the returned recalled units. Distributors were requested to notify their accounts of the recall. The letter requested users to complete and return an enclosed response sheet, indicating the number of units to be replaced or returned for credit. For additional information, contact 866-359-1704. |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043520 | EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR Emg Technology Co., Ltd., Oct 21, 2005 |