—#132643

Product

MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

FDA product code: BYD — Condenser, Heat And Moisture (Artificial Nose)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Lot numbers: 201413, 201414, 201415, 201417, 201419 and 201422.

Why it was recalled

Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were notified by an Urgent - Field Safety Notice, dated 01/12/2015. The letter identified the affected devices, a description of the problem, and actions to be taken. Customers were asked to check their inventory for any affected product, to cease use and distribution, and immediately quarantine any affected product. Customers are to complete and return the Acknowledgement form and to their local MAQUET representative, who provide a return number. A credit will be issues upon receipt of the affected product. Customer should contact their local MAQUET representative at fieldactions@maquet.com with questions or for support this issue.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: Distributed to FL, KS, MI and WV.

Timeline

Recall initiated: 2015-01-12
Posted by FDA: 2015-02-06
Terminated: 2016-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132643. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.