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

FDA device recall Z-1558-2015 · posted 2015-04-30 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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

Action taken

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

Status

Terminated

Product code

BTT

Quantity affected

7,228 units

Distribution

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

Date initiated

2015-04-01

Date posted

2015-04-30

Date terminated

2025-03-05

Location

Research Triangle Park, NC

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