BEUDAMED
    FDA Recall Open, Classified

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.

    Recall: Z-1188-2023 · Initiated February 13, 2023

    Recall

    Recall Number
    Z-1188-2023
    Event Number
    91569
    Firm
    Maquet Medical Systems USA
    FEI Number
    3008355164
    Product Code
    DTZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 13, 2023
    Posted
    February 28, 2023
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.

    Reason

    Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.

    Action

    On February 13, 2023, the firm notified customers via Urgent Medical Device Correction letters. Customers were informed of the potential packaging issues and the associated risks to health. Customers were instructed to stop use and return all unused and unexpired affected product for credit. If customers have no alternative product, they may choose to continue use of the product, but they must perform a visual inspection of the primary packaging, checking for visible stress marks or damage to the packaging. If there are visible stress marks in the packaging, the customer should not use the product. Please note that there is a possibility that packaging defects may not be detectable by the naked eye. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 9GETUSA / (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czechia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Myanmar, Mexico, Moldova, Morocco, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of North Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Republic of Korea, The Russian Federation, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.

    Quantity

    10,587 units (US); 94,987 (worldwide)