{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198190", "product_res_number": "Z-1188-2023", "event_date_initiated": "2023-02-13", "event_date_posted": "2023-02-28", "recall_status": "Open, Classified", "res_event_number": "91569", "product_code": "DTZ", "k_numbers": [ "K112360" ], "product_description": "BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, \n\nBEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. \nPart of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.", "code_info": "HLS Set Advanced 5.0, Product Code 70106.9077\nUDI-DI 04058863076355\n\nHLS Set Advanced 7.0, Product Code 70106.9078\nUDI-DI 04058863080383\n\nAll lots/batches affected", "firm_fei_number": "3008355164", "recalling_firm": "Maquet Medical Systems USA", "address_1": "45 Barbour Pond Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470-2094", "additional_info_contact": "Allison Jean Kaplan\n973-709-7779", "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.", "root_cause_description": "Process control", "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.\n\nCustomers were instructed to stop use and return all unused and unexpired affected product for credit.\n\nIf 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. \n\nPlease note that there is a possibility that packaging defects may not be detectable by the naked eye.\n\nIf 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).", "product_quantity": "10,587 units (US); 94,987 (worldwide)", "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,\nHungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia,\nLebanon, 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.", "openfda": { "k_number": [ "K861177", "K962667", "K851035", "K000430", "K121536", "K830639", "K140774", "K941653", "K150267", "K911227", "K974085", "K223161", "K162896", "K061031", "K100645", "K201916", "K022115", "K893704", "K071494", "K072362", "K964967", "K850630", "K090449", "K863476", "K101153", "K122844", "K250821", "K863249", "K896671", "K130359", "K812660", "K183511", "K231982", "K803003", "K231773", "K853251", "K962641", "K810470", "K860673", "K841476", "K072091", 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