{ "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": "184413", "product_res_number": "Z-0711-2021", "event_date_initiated": "2020-08-31", "event_date_created": "2020-12-23", "recall_status": "Open, Classified", "res_event_number": "86426", "product_code": "FJK", "k_numbers": [ "K983559" ], "product_description": "26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795", "code_info": "Lots: 4758192, 4763891, 4794293, 4807842, 4849283, 4866670, 4877784, 4902534, 4909635                                                     ,", "firm_fei_number": "2025816", "recalling_firm": "ICU Medical, Inc.", "address_1": "951 Calle Amanecer", "city": "San Clemente", "state": "CA", "postal_code": "92673-6212", "additional_info_contact": "949-366-2183", "reason_for_recall": "Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.", "root_cause_description": "Process control", "action": "On 08/31/2020, Medical Device Recall notices were mailed to customers informing them to take the following actions:\n\n1) Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility.\n2) Inform potential users of the product in your organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if you do not have the affected product.\n3) ICU Medical has some lots of unaffected product available today and is actively increasing the amount of available inventory. In the event specific product is unavailable, consider use of the non-spinning Spiros or the ChemoLock CSTD as alternatives. Please contact customer service for product availability.\n4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-888-871-7108 (MF, 8am-5pm ET) if you have not received a return label or require additional labels for returning the affected product.\n5) If you have distributed the product further, immediately notify your accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle to obtain a response form.\n\nFor further inquiries, please contact: Global Complaint Management, 1-844-654-7780 or ProductComplaintsPP@icumed.com; Customer Service, 1-866-829-9025, option 8 or, customerservice@icumed.com, (M-F, 8am-6pm CT)\n\nOn 10/07/2020, the Medical Device Recall notice, with an expanded affected device scope, was sent to customers.", "product_quantity": "2900", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution including in the states of FL, MD, LA, PA, IN, TX, NY, MO, VA, OH, GA, NC, IL, CA, AZ, AK, NE, DE, WI, CO, UT, ND, MS, MA, MN, WA, SC, OR, KS, MI, NH, NJ, KY, TN, ID, AR, CT, OK, AL, SD, ME, IA, VT, WY, DC, NV, RI, MT, NM, HI, WV and the countries of Italy, Belgium, United Kingdom, Canada, Germany, Argentina, Australia, Poland, Greece, Switzerland, Israel, France, Finland, Spain, Malaysia, Taiwan, Ireland, Luxembourg, Hong Kong , Brazil, Netherlands, Austria, Sweden, Turkey, Singapore, Slovakia, Croatia, South Africa, Romania, Thailand.", "openfda": { "k_number": [ "K852309", "K812685", "K063293", "K243607", "K983559", "K120823", "K251442", "K853851", "K934803", "K070414", "K811839", "K870722", "K761326", "K000451", "K210782", "K962081", "K801016", "K992039", "K063290", "K801211", "K884243", "K792053", "K202796", "K821138", "K810823", "K903021", "K854271", "K810824", "K100364", "K792054", "K252423", "K013634", "K953823", "K820169", "K952631", "K802874", "K161582", "K012242", "K001107", "K201866", "K982340", "K831747", "K213992", "K971313", "K892932", "K072024", "K171952", "K150304", "K140841", "K032975", "K852605", "K860740", "K251341", "K864784", "K831424", "K992930", "K001873", "K830677", "K901688", "K771693", "K920797", "K090255", "K853962", "K873455", "K780681", "K971687", "K913526", "K950247", "K014140", "K080807", "K896407", "K873516", "K902426", "K921597", "K851236", "K112628", "K910558" ], "registration_number": [ "2028411", "8030638", "3005578748", "2011171", "9611824", "3006755813", "3009746061", "8041145", "3010377171", "3013546453", "3017552925", "2029275", "2032098", "3013671177", "2032112", "3006849754", "3010355846", "1225714", "9680579", "3035708507", "3004111573", "3008044552", "3014936217", "9611823", "3014279513", "3004960482", "3013764800", "1056186", "3000247873", "3032828299", "3043534762", "9617594", "2025816", "3005246939", "3015335038", "3038138522", "3038195011", "3042158867", "1649518", "9610270", "3003589956", "2521402", "3020689844", "2024024", "3030446844", "9611369", "3013536188", "9616419", "3032143970", "1018470", "3004530184", "3013217742", "8030639", "3011163668", "3010291427", "3044744771", "8030665", "3043014136", "1650907", "9614279", "3017636737", "3006795797", "3015349756", "3005162618", "3016096143" ], "fei_number": [ "3002807005", "3005578748", "2011171", "3003076831", "3006755813", "3009746061", "3010377171", "3001236277", "3013546453", "3017552925", "1000132332", "3013671177", "3003656001", "3006849754", "3010355846", "1000306431", "3002807744", "3002806727", "3002807035", "1000203464", "3035708507", "3004111573", "3002974635", "3008044552", "3014936217", "3004960482", "3013764800", "3032828299", "3000247873", "3043534762", "2025816", "3005246939", "3015335038", "3038138522", "3038195011", "3003767881", "3042158867", "3003589956", "2521402", "3020689844", "2024024", "3030446844", "3012394756", "3013536188", "3032143970", "1018470", "3004530184", "3013217742", "3003058448", "1527681", "3011163668", "3010291427", "3002681132", "3044744771", "6898", "3043014136", "3002806960", "3003807466", "3017636737", "1000125241", "3006795797", "3015349756", "3014279513", "3016096143", "3001451489" ], "device_name": "Set, Tubing, Blood, With And Without Anti-Regurgitation Valve", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5820", "device_class": "2" } } ] }