Recall Z-1473-2008
Medline Industries Inc · initiated March 4, 2008
Product
Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; 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.
Codes / lots: Reorder Number: HCS02; All units produced since July 2006.
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1473-2008
- Initiated
- March 4, 2008
- Posted by FDA
- July 23, 2008
- Terminated
- June 17, 2010
- Product code
- CAW – Generator, Oxygen, Portable
- Distribution
- Nationwide Distribution
- Recalling firm
- Medline Industries Inc, Mundelein, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1474-2008 | Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator…Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to… | 03/04/2008Terminated |