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FLOW-i Anesthesia System recallZ-1706-2015 · Maquet Cardiovascular Us Sales, Llc · initiated Apr 2, 2015

Class I Terminated All recalls posted in June 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Cardiovascular Us Sales, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1706-2015
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Apr 2, 2015
Posted by the FDA
Jun 8, 2015
Recalling firm
Maquet Cardiovascular Us Sales, Llc
Quantity
1641 [80 units (US) 1561 units (OUS)]
Product code
BSZ
FDA submissions
K133958
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, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Libya, Mexico, Mongolia, Mozambique, Netherlands, Norway Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Unites States, and Venezuela.

Product description

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

Code information (models, lots, serial numbers)

Article number 66 77 200 66 77 300 66 77 400  Serial Numbers 1058 1646 2034 2723 1059 1647 2095 2724 1060 1648 2186 2729 1172 1650 2554 2731 1201 1651 2555 2732 1202 1652 2556 2733 1204 1653 2557 2735 1224 1654 2558 2736 1225 1655 2559 2737 1226 1656 2560 2738 1277 1657 2561 2739 1280 1786 2562 2740 1281 1787 2613 2741 1282 1860 2714 2742 1545 1861 2716 2743 1546 2021 2719 2744 1643 2022 2720 2745 1644 2023 2721 2746 1645 2024 2722 2747

Other devices under the same FDA submission

2 devices cleared under K133958 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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