Recall Z-1051-2015
Teleflex Medical · initiated January 12, 2015
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: Lot numbers: 201413, 201414, 201415, 201417, 201419 and 201422.
Reason for recall
Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1051-2015
- Initiated
- January 12, 2015
- Posted by FDA
- February 6, 2015
- Terminated
- May 10, 2016
- Product code
- BYD – Condenser, Heat And Moisture (Artificial Nose)
- Quantity
- 100 units
- Distribution
- Distributed to FL, KS, MI and WV.
- Recalling firm
- Teleflex Medical, Durham, NC