Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a

FDA device recall Z-2374-2016 · posted 2016-08-09 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Cracks may occur at the 15mm and 22mm ISO female connector.

Action taken

Inmed, a division of Teleflex sent an Urgent Field Safety Notice letter dated December 3, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, cease use and distribution of stock of the affected product batch and quarantine immediately.. The letter included an acknowledgment form which was to be completed and returned your MAQUET representative. For further information or support concerning this issue, contact your local MAQUET representative at fieldactions@maquet.com. For questions contact your local sales representative or Customer Service.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

BYD

Quantity affected

2,700 ea.

Distribution

US Nationwide Distribution in the states of FL, KS and WV.

Date initiated

2015-12-03

Date posted

2016-08-09

Date terminated

2017-04-14

Location

Morrisville, NC