MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Recall
- Recall Number
- Z-2683-2016
- Event Number
- 74793
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- BYD
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 3, 2015
- Posted
- August 29, 2016
- Terminated
- January 24, 2017
- Address
- 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437
Description
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Cracking may occur at the 15mm and 22mm ISO female connector.
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 [email protected]. 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.
US Distribution to the states of : FL, KS, and WV.
2,700 units