Use: The Flow-i Anesthesia System administers anesthesia while providing ventilation to patients with no or limited ability to breathe. The system is used in hospitals, for use in a range of patients from neonatal to adult.
Recall Class: Class I
Date Recall Initiated: April 2, 2015
Device: FLOW-i Anesthesia Systems
- Article Numbers: 66 77 200, 66 77 300, 66 77 400
- Manufacturing and Distribution Dates: July 7, 2015 to May 5, 2014
- Number of Units Distributed in the U.S.: 1641
Recalling Firm:
Maquet Critical Care AB
45 Barbour Pond Drive
Wayne, New Jersey 07470
Reason for Recall: The firm has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient cassette from its mount when users perform a change of system. This may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
The firm has received 10 reports this device has malfunctioned; no injuries or deaths have been reported.
Public Contact: For questions regarding this field action, please contact a Maquet Service Representative or Maquet Technical Support at 1-888-627-8383 (Press option 3, followed by option 1 and then option 1 again), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EST.
FDA District: New Jersey District Office
More Information about this Recall:
On April 2, 2015, Maquet Critical Care AB sent an urgent medical device field correction notice to consignees making them aware of the issue. Consignees were given instructions to verify the serial number of the device and recommendations for a dislodged patient cassette.
A Maquet Service representative will contact consignees to arrange replacement of the FLOW-i Anesthesia System patient cassette locking device.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.