Recalls / —

—#148469

Product

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

FDA product code

BYD — Condenser, Heat And Moisture (Artificial Nose)

Device class

Class 1

Medical specialty

Anesthesiology

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Teleflex Medical

Address

3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern

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

Timeline

Recall initiated

2015-12-03

Posted by FDA

2016-08-29

Terminated

2017-01-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #148469. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.