FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonata

FDA device recall Z-1706-2015 · posted 2015-06-08 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Reason for recall

In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.

Action taken

The firm, Maquet Inc., sent an "Urgent Medical Device Field Action Field Correction for FLOW-i Anesthesia Systems" letter dated 4/2/2015 via FedEx. The letter describes the product, problem and actions to be taken. The customers were instructed to read the letter and inform staff, who may use the FLOW-i Anesthesia System of the patient cassette locking device issue. Customers are to obtain the serial number of their system; verify the serial number obtained against the serial number listed in the box in the Appendix. A Maquet Service Representative will be contacting you to arrange a convenient time to replace your FLOW-i Anesthesia System patient cassette locking device. If you have any questions regarding this field action, please contact your 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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

BSZ

Quantity affected

1641 [80 units (US) 1561 units (OUS)]

Distribution

Class I Recall - Worldwide distribution -- US, including the states of AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, and WV; and, countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, C

Date initiated

2015-04-02

Date posted

2015-06-08

Date terminated

2016-07-06

Location

Wayne, NJ

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