{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "150513", "product_res_number": "Z-0435-2017", "event_date_initiated": "2016-09-27", "event_date_posted": "2016-11-15", "recall_status": "Terminated", "event_date_terminated": "2017-07-11", "res_event_number": "75491", "product_code": "DRS", "k_numbers": [ "K061573" ], "product_description": "TRANSPAC IV TRIFURCATED MONITORING KIT, 84\" 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42590-08\nThe Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.", "code_info": "3226281 3264110", "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": "ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits\ncontaining the Transpac IV transducers.", "root_cause_description": "Device Design", "action": "ICU Medical sent an Urgent Medical Device Recall Notification letter dated September 27, 2016, to all affected customers to inform them of the expanded recall of the monitoring kits with Transpac IV transducers. Customers were informed of updated communications from August 10, 2016, when ICU Medical sent a communication indicating a potential leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. Based on continued evaluation, ICU Medical is expanding the notification to now include certain other monitoring kits that contain the Transpac IV transducers. A small number of these devices may have the potential to leak or potentially introduce small amounts of air into the line. Customers with questions were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 2, or e-mail the following address: productreturns@icumed.com. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to recall@icumed.com. Customers with questions were instructed to call 866-829-9025.", "product_quantity": "730 units", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K812758", "K851888", "K841613", "K831348", "K853996", "K812530", "K833095", "K810661", "K811980", "K172458", "K810431", "K820186", "K101518", "K841811", "K850898", "K820457", "K840274", "K881297", "K882118", "K780127", "K091408", "K152980", "K961404", "K840023", "K904777", "K781680", "K831867", "K771361", "K242909", "K823286", "K792020", "K841960", "K883095", "K102033", "K851989", "K832897", "K801048", "K820459", "K052828", "K801136", "K831698", "K832907", "K221782", "K833094", "K870301", "K101189", "K833096", "K851987", "K822507", "K884919", "K870356", "K855145", "K841968", "K951722", "K791636", "K833170", "K840121", "K813053", "K854596", "K780128", "K813502", "K821894", "K123095", "K813266", "K823334", "K862344", "K864090", "K842352", "K813549", "K112203", "K930888", "K802179", "K884235", "K103715", "K151040", "K820579", "K120624", "K872596", "K852652", "K820677", "K830210", "K163172", "K820046", "K802069", "K885296", "K761325", "K833792", "K820342", "K841788", "K902472", "K983372", "K902453", "K900551", "K820201", "K821416", "K062342", "K981747", "K801239", "K871371", "K833171", "K920977", "K801985", "K800706", "K771668", "K910764", "K092644", "K843580", "K820355", "K921343", "K833271", "K792073", "K070710", "K832657", "K813137", "K780797", "K152472", "K810637", "K813267", "K854505", "K820202", "K951129", "K810009", "K820676", "K831506", "K812884", "K873168", "K830093", "K843273", "K811538", "K810735", "K851988", "K043065", "K790407", "K921898", "K821450", "K800705", "K981745", "K803096", "K851486", "K860681", "K813464", "K133624", "K780477", "K812883", "K904601", "K801138", "K061573", "K161408" ], "registration_number": [ "", "9617594", "9610849", "3009077524", "3005012805", "3018094310", "2648727", "3007307487", "1526863", "1054241", "1724474", "3004605321", "3013783488", "2032112", "3008496528", "9681377", "3016618143", "3008403546", "3002907620", "1928237", "3004111573", "1721676", "8020616", "2221819", "1061124", "1218950", "3033589330", "3015173212", "9616675", "9612152", "1713468", "2936999", "3004832480", "3017636737", "2025816", "3009106351", "3032916632", "1417592", "3015309643", "3007836437", "3000126629", "9616088", "3013319212", "3012536737", "1423537", "1423395", "3006891665", "1649914", "9616567", "1625425", "1043214", "8043969", "3017987980", "3005580113", "3011237704", "3015910259", "3012542015", "3009156722", "8043983", "2246552", "1721504", "8010042", "3006082230", "9615817", "3006950086", "3004519921", "3009001657", "9610816", "3010421104", "1718873", "1055236", "3003263092", "3005941719", "1018233", "3007048453", "3016701404", "3012528160", "3013596024", "1319639", "3014541700", "3031233007", "1422634", "3015225571", "3007603826", "3013500228", "3005595283", "2648045", "3008693658" ], "fei_number": [ "", "3003076831", "3009077524", "3005012805", "3018094310", "2648727", "3007307487", "3004050362", "1526863", "3004605321", "3013783488", "3008496528", "3016618143", "3008403546", "3002907620", "1928237", "3004111573", "1000138054", "1721676", "1000300598", "2221819", "1000514656", "1218950", "3033589330", "3016261803", "3015173212", "3002806901", "1713468", "2936999", "3005846326", "3004832480", "3017636737", "2025816", "3009106351", "3032916632", "1417592", "3015309643", "1000112877", "3007836437", "3000126629", "3003094851", "3013319212", "3012536737", "3002807391", "3006891665", "3002902735", "3003081151", "3001236905", "1625425", "1043214", "3017987980", "3005580113", "3001665800", "3011237704", "3003105967", "3015910259", "3012542015", "1000512168", "3009156722", "2246552", "1721504", "3006082230", "3006950086", "3003807466", "3002807167", "3009001657", "3002808128", "3002806476", "3000717925", "3010421104", "1718873", "1000112968", "3003263092", "1018233", "3007048453", "3016701404", "3002807111", "3012528160", "3013596024", "3014541700", "3031233007", "3015225571", "3002963732", "3007603826", "3013500228", "3005595283", "2648045", "3008693658" ], "device_name": "Transducer, Blood-Pressure, Extravascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2850", "device_class": "2" } } ] }