{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161214", "product_res_number": "Z-0779-2019", "event_date_initiated": "2017-08-02", "event_date_created": "2019-01-28", "recall_status": "Terminated", "event_date_terminated": "2020-08-06", "res_event_number": "79031", "product_code": "CAC", "k_numbers": [ "K101907" ], "product_description": "Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70\n\nIndications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.", "code_info": "Catalog number: CSE-P-70", "firm_fei_number": "1219343", "recalling_firm": "Haemonetics Corporation", "address_1": "400 Wood Rd", "city": "Braintree", "state": "MA", "postal_code": "02184-2412", "additional_info_contact": "Ian Purdy\n800-537-2802", "reason_for_recall": "Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.", "root_cause_description": "Process control", "action": "On August 2, 2017, the firm, Haemonetics, sent a customer notification letter titled \"URGENT Medical Device Recall for 70ml Centrifuge Bowls\" to all customers. The letter informs the customers of the risk to health, actions to be taken and the product and distribution information. Action to be Taken by Customer: Please discontinue use of the products listed in the letter and return any unused product to Haemonetics. Contact your local customer service representative at 800-537-2802 to coordinate the return, shipment and credit receipt of unused product.\n \nCustomers were also instructed to complete and return the RECALL ACKNOWLEDGEMENT FORM BY FAX TO +1-781-356-3558 OR SCAN AND\nE-MAIL TO CORPORATEREGULATORY@HAEMONETICS.COM.\n\nCustomers with questions or concerns are instructed to call the Customer Support Team at 800-537-2802 or email at customerservicena@haemonetics.com.", "product_quantity": "4576 units", "distribution_pattern": "US Nationwide Distribution to states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, ME, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI.", "openfda": { "k_number": [ "K221722", "K022348", "K831557", "K812355", "K031554", "K915130", "K912610", "K974897", "K862684", "K112245", "K897126", "K932890", "K883934", "K931899", "K160735", "K897127", "K022167", "K871258", "K231782", "K882757", "K830735", "K900299", "K902759", "K881421", "K043140", "K893402", "K875023", "K781552", "K871847", "K940519", "K881350", "K925827", "K103202", "K920618", "K843821", "K221483", "K162423", "K992723", "K120586", "K952224", "K953118", "K991986", "K942844", "K854301", "K920273", "K881631", "K791891", "K960734", "K910211", "K913247", "K940678", "K831849", "K864374", "K892819", "K020647", "K041525", "K911656", "K802674", "K955010", "K122262", "K881683", "K873807", "K926338", "K912609", "K932093", "K811228", "K960006", "K933960", "K193361", "K895297", "K901401", "K014187", "K140197", "K902671", "K931552", "K871568", "K903392", "K120953", "K101586", "K970857", "K890171", "K924894", "K913177", "K984233", "K892857", "K060482", "K883082", "K872590", "K962475", "K931106", "K781550", "K014083", "K912019", "K914119", "K872162", "K210862", "K973378", "K942791", "K842610", "K896857", "K904474", "K910991", "K973627", "K904888", "K043127", "K872160", "K210176", "K884564", "K872927", "K012406", "K904041", "K012178", "K904164", "K201305", "K896858", "K982241", "K131553", "K781553", "K772196", "K963850", "K893218", "K951592", "K180831", "K900325", "K901232", "K970714", "K893578", "K972894", "K904515", "K945775", "K781551", "K964070", "K881129", "K852425", "K772280", "K872814", "K210089", "K923016", "K894668", "K963759", "K913181", "K140205", "K851024", "K053000", "K852736", "K871624", "K110782", "K240426", "K884844", "K101907", "K962689", "K852178", "K892443", "K910238", "K913773", "K192368", "K902059", "K241236", "K900483", "K912956", "K914053", "K860306", "K240584", "K883663", "K812292", "K181954", "K982755", "K982712", "K963758", "K982660", "K936220", "K902713", "K093535", "K872158", "K983022", "K944232", "K881692", "K880162", "K901138", "K963098", "K883058", "K861677", "K894294", "K893394", "K904794", "K993581", "K024097", "K971274", "K082923", "K982650", "K022489", "K160197", "K130043", "K913684", "K933625" ], "registration_number": [ "2029015", "3010009632", "9680425", "9617601", "3019807891", "3008810357", "2184009", "1836518", "3006654680", "3031823122", "1526534", "1219343", "2029275", "3010041511", "8022032", "1424263", "3005012805", "1928237", "9611109", "1220477", "3010413216", "3011554160", "1724474", "1718850", "9680841", "3004593495", "3015219237", "1064858", "3011137372", "3011175548", "3010084488", "3011773324", "3020347218", "9612051", "2528981", "3010273872", "3007923088", "3010220595", "9617787", "9681630", "3009380063", "2032112", "3004111573", "9615908", "3004142400", "3004634229", "3011270181", "3004365956", "2011171", "8043817", "9680143", "3016994551", "3004548776", "3044156918", "3010291427" ], "fei_number": [ "3010009632", "3003282181", "3001717360", "3007596547", "3003094851", "3008810357", "3019807891", "3002808267", "3003094575", "3006654680", "1000116158", "1526534", "1219343", "3010041511", "3005012805", "3003015552", "1928237", "3002806457", "3002807308", "3010413216", "1220477", "3011554160", "3008397795", "3002808845", "1000306431", "1718850", "3004593495", "3015219237", "3003076831", "3011175548", "3010084488", "3011773324", "3020347218", "3005426550", "2528981", "3002534070", "3010273872", "3003327833", "3007923088", "3010220595", "3005747797", "3009380063", "1000160458", "3004111573", "3004142400", "3004634229", "3011270181", "3004365956", "2011171", "3031823122", "3016994551", "3003261020", "3004548776", "3044156918", "3010291427" ], "device_name": "Apparatus, Autotransfusion", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5830", "device_class": "2" } } ] }