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Terminated

Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.

FDA Recall Z-1558-2015 · Posted 2015-04-30

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTT
Date Initiated2015-04-01
Date Terminated2025-03-05
Product Quantity7,228 units

Reason for Recall

Customer complaints were received of power to the unit ceasing and the display going blank.

Firm Action

Teleflex sent an Urgent - Medical Device Notification letter dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were informed that Teleflex Medical would exchange all of the potentially impacted units in the field with the Neptune Heated Humidifier with ConchaSmart" Technology. In the meantime, they were instructed to continue to follow hospital and departmental protocol regarding the regular monitoring of the patient and the product during treatment. If the unit display is blank, replace it with another unit and call Teleflex for an immediate replacement. A Recall Acknowledgement Form was attached to be completed, scanned and returned to Teleflex Medical to document receipt of this Notification. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide and Internationally to the countries of: Belgium and Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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