Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS021; Packaged
FDA device recall Z-1474-2008 · posted 2008-07-23 · Terminated
Recall details
- Recalling firm
- Medline Industries Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CAW
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-03-04
- Date posted
- 2008-07-23
- Date terminated
- 2010-06-17
- Location
- Mundelein, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR (K043520) | Emg Technology Co., Ltd. | 2005-10-21 |