Recall Class: Class I
Date Recall Initiated: December 4, 2014
Device: MAQUET Servo Humidifier 163
- Manufactured from September 1, 2012 through September 30, 2013
- Distributed from June 1, 2013 through November 30, 2014
- Distributed in Florida, Michigan, West Virginia, and Kansas (18 devices in total)
- Model Number: 01-06-8125-8
- Catalog Number: XKC01-06-8125-8
- Lot Numbers: 201321, 201323, 201324
See related Class I Recall notice.
Use: The MAQUET Servo Humidifier is a heat and moisture condenser that is placed over a surgically-created opening in the throat (tracheotomy) or a tube inserted into the trachea to warm and moisten gases breathed in by a patient. The primary users of this device are nurses and respiratory therapists.
4024 Stirrup Creek Drive, Suite 720
Durham, North Carolina 27703
INMED Manufacturing SDN BHD (a division of Teleflex)
IDA Business & Technology Park
Athlone Co. Westmeath, Ireland
Reason for Recall: Some connector cracks were found when preparing patients for support with a ventilator. These cracks may lead to oxygen and other gases leaking from the ventilator and not delivering sufficient treatment to patients, potentially causing serious injury or death.
Public Contact: For further information or support concerning this recall, contact your local Maquet representative at firstname.lastname@example.org.
FDA District: Philadelphia District Office
More Information about this Recall:
INMED sent customers an Urgent - Field Safety Notice dated December 4, 2014. The notice identified the product, problem, and action to be taken.
Health Care Facilities were requested to:
- Immediately check inventory.
- Quarantine and discontinue use of the device.
- Return the acknowledgement form sent with the notice back to Maquet within five days of receipt.
- Request a return authorization form from Maquet for the recalled devices.
Additionally, distributors were requested to:
- Immediately stop distributing the recalled device.
- Send the Urgent Field Safety Notice to customers.
- Request customers to complete the acknowledgement form sent with the notice within five days of receipt and return to you.
- Forward the completed acknowledgement form back to Maquet.
About Class I Recalls:
Class I recalls are the most serious type of recall. They involve situations when it is likely that use of these devices will cause serious health problems or death.
Health care professionals and consumers can report bad reactions or quality problems they had using the device to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.