—#69063

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.

FDA product code: CAW — Generator, Oxygen, Portable
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K043520
Affected lot / code info: Reorder Number: HCS02; All units produced since July 2006.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4486

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2008-03-04
Posted by FDA: 2008-07-23
Terminated: 2010-06-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69063. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.