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.
FDA Recall Z-1474-2008 · Posted 2008-07-23
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Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeCAW
Date Initiated2008-03-04
Date Terminated2010-06-17
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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