{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184564", "product_res_number": "Z-0633-2021", "event_date_initiated": "2020-11-20", "event_date_created": "2020-12-17", "recall_status": "Terminated", "event_date_terminated": "2024-11-07", "res_event_number": "86796", "product_code": "DTZ", "k_numbers": [ "K112360" ], "product_description": "HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.", "code_info": "Model Number: BEQ-HLS 7050 Part Number: 70105.2794 UDI Code: 04037691773513 Lot Codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038", "firm_fei_number": "3008355164", "recalling_firm": "Maquet Cardiovascular Us Sales, Llc", "address_1": "45 Barbour Pond Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470-2094", "additional_info_contact": "Allison Jean Kaplan\n973-709-7000", "reason_for_recall": "The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.", "root_cause_description": "Package design/selection", "action": "Actions to be taken:\n\nPlease examine your inventory immediately to determine if you have any of the affected HLS Set Advanced with the product codes and lot numbers listed on page 1 of this notice and acknowledge that you have received this notification by following the instructions below. \n\nIf an affected device is already in use, please continue using according to normal practices. \n\nShould you have any un-used and un-expired affected product you are eligible to return the affected product for credit. Please contact Getinge Customer Service at (888) 9GETUSA / (800) 943-8872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. \n\nPlease also enter the affected lot numbers, quantity and RMA number provided by Customer Service in the spaces provided on the Medical Device Recall Expansion - Removal Response Form on Page 4 of this letter, if you are returning products to Maquet/Getinge. \n\nPlease complete and sign the attached MEDICAL DEVICE RECALL Removal RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to acthlsset2020.us@getinge.com or by faxing the form to (800) 866-5751.\n\nThis voluntary recall only affects the products listed on page 1; no other products are affected by this voluntary recall.\n\nAdverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax using the following:\n\"\tOnline: www.accessdata.fda.gov/scripts/medwatch/\n\"\tRegular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malaysia, Mexico, Moldavia, Montenegro, Morocco, Myanmar, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand,Turkey, United Arab Emirates, United Kingdom, Vietnam.", "openfda": { "k_number": [ "K831122", "K242503", "K990103", "K861641", "K894970", "K223161", "K910107", "K241352", "K912655", "K790356", "K022115", "K140177", "K961530", "K863249", "K872133", "K802328", "K810470", "K811004", "K843955", "K772237", "K102464", "K974085", "K862918", "K191444", "K802719", "K202510", "K103191", "K925626", "K823125", "K802720", "K231414", "K901253", "K050447", "K061628", "K891230", "K932252", "K843956", "K133261", "K810532", "K200683", "K212341", "K964043", "K893704", "K183490", "K872107", "K897068", "K923272", "K833518", "K090450", 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