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.

FDA Recall Z-1188-2023 · Posted 2023-02-28

Recalling FirmMaquet Medical Systems USA

Recall StatusOpen, Classified

Product CodeDTZ

Date Initiated2023-02-13

Product Quantity10,587 units (US); 94,987 (worldwide)

Reason for Recall

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.

Firm 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).

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112360QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIESMaquet Cardiopulmonary, AG · 2011-09-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.