FDAClass IISeptember 7, 2016

MAQUET Servo Humidifier 163 recall

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

Why was MAQUET Servo Humidifier 163 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model number: 01-06-8125-8, Product code: XKC01-06-8125-8, Lot numbers: 201450, 201451, 201452 and 201504.

Product
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Recalling firm
Teleflex Medical
Quantity
2,700 units
Distribution
US Distribution to the states of : FL, KS, and WV.
Recall date
September 7, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls