Recall Z-2683-2016— Teleflex Medical

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2015-12-03, terminated 2017-01-24. FDA's recall record names no specific 510(k) clearance for this event. Product: MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.. Reason: Cracking may occur at the 15mm and 22mm ISO female connector..

Recalling firm
Teleflex Medical
Classification
Class II
Status
Terminated
Initiated
2015-12-03
Terminated
2017-01-24
Firm location
Morrisville, NC, United States

Product description

MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.