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

FDA device recall Z-2683-2016 · posted 2016-08-29 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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

Action taken

INMED sent an Urgent - Field Safety Notice dated December 3, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to cease use and distribution of stock of the affected product batch and quarantine immediately. Customers are to return all affected product to MAQUET. An Acknowledgement form was included to be completed and returned to their MAQUET representative. If the product was distributed, they were instructed to provide the field safety notice to all of their customers who have received product in scope of the Field Action. Their customer is then required to complete the Acknowledgement form and return it to them. Should you require any further information or support concerning this issue, please contact your local MAQUET representative at fieldactions@maquet.com. INMED is committed to providing high quality, safe and effective products. W e sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service. For further questions, please call (610) 378-0131.

Root cause

Device Design

Status

Terminated

Product code

BYD

Quantity affected

2,700 units

Distribution

US Distribution to the states of : FL, KS, and WV.

Date initiated

2015-12-03

Date posted

2016-08-29

Date terminated

2017-01-24

Location

Morrisville, NC