{ "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": "2026-07-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Ann Arbor", "state": "MI", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "94083", "recalling_firm": "Terumo Cardiovascular Systems Corporation", "address_1": "6200 Jackson Rd", "address_2": "", "postal_code": "48103-9586", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand.", "recall_number": "Z-1401-2024", "product_description": "Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534 75607 75765 75797 75833 75903 75956 75973 76131 76178 76278 76306 76398 76427 76498 76519 76536 76565 76575 76628 76630 76635 76644 76687 76725 76775 76789 76832 76839 76878 76900 76999 77010 77014 77015 77105 77227 77299 77304 77305 77412 77450 77496 77516 77629 77722 77742 77757 77791 77794 77796 78018 78027 165720 205307A 65046-03 65080-06 65167-06 65934-01 65940-01 66041-01 66154-01 66503-02 70148-02 70178-06 70188-05 70638-07 70664-02 70665-01 70734-03 71064-01 71432-02 71433-01 71546-02 71733-02 71754-04 71801-02 71820-01 71928-06 71934-04 72073-02 72149-01 72226-06 72326-07 73008-02 73346-01 73567-01 73568-01 73776-04 73783-02 73882-03 74172-03 74685-01 74734-01 74833-01 74879-07 74921-02 74965-03 74965-04 74972-01 75030-01 75050-02 75068-01 75159-01 75293-01 75409-01 75409-02 75410-01 75410-02 75540-03 75540-05 75572-01 75642-02 75688-01 75790-02 75834-01 75927-01 75959-01 75972-01 76178-01 76273-01 76278-01 76308-01 76326-02 76372-01 76373-01 76374-01 76376-01 76491-01 76732-02 76873-02 77012-02 77127-01 77316-01 77496-01 77502-01 77521-01 77532-01 77655-01 77791-01 B75409 B75410 B75903 B76178 B76278", "product_quantity": "20,533 units", "reason_for_recall": "Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention", "recall_initiation_date": "20240220", "center_classification_date": "20240329", "report_date": "20240410", "code_info": "Product Number/Product Name/GTIN/Lot Numbers: 16010 CARDIOPLEGIA SET 4:1 RATIO NO RECIRC 00699753001534 2L05 2L12 2L19 2P19 165720; 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X-COATED FX PRESCRIPTIVE PACK 00699753501782 0000457906 75765; X-COATED PEDIATRIC PACK 00699753507593 301108396 75790-02; X-COATED FX PACK WITH CP50 00699753517424 0000439904 302110334 304111757 75797; X-COATED PERFUSION PACK 00699753529359 0000450281 0000455794 75833; X-COATED CPG 4:1 AND 1:4 PACK 00699753500273 302110002 306112369 309114431 75834-01; MEDSTAR FX25 PUM;K AND 00699753516007 0000311783 0000311784 0000311785 0000441645 0000459159 242104755 243104756 245104757 247104758 249108447 249109194 304110881 306112584 306114124R 306114374R 307112649 307114674R 307114907R 75903; X-COATED TRINIDAD FX25 PACK 00699753505209 249106074 249106075 75927-01; X-COATED MAIN; PACK 00699753505940 0000311778 0000311779 0000450299 0000453302 250107942 251107245 75956; CONDUCER/MP4 8:1 FOR FX OXY 00699753501713 0000453279 243101157 243102725 244103328 249103341 249105017 249106083 249106938 301108194 301108989 301109523 304110052 304112721 75959-01; X-COATED HARLINGEN BROWNSVILLE 00699753516229 0000311058 0000311651 247106394 249107927 75972-01; X-COATED FX LOW PRIME PACK 00699753515758 0000440678 0000459133 244105238 244105239 245106542 247107266 250109189 250109190 250109220 250109221 306114101R 306114116R 306114375R 306114383R 307113458 307114537R 75973; ALLEGIANCE FX PACK 00699753502895 0000324368 0000324369 302106395 76131; OPEN HEART3/8X1/2CP50X-COAT 00699753504813 0000326843 0000328593 0000452204 0000452205 244105783 247107192 249108821 249109153 251109769 301110303 303111443 305112578 76178; ADULT BASIC PACK DOMINICAN REP 00699753506657; 251108129 251108129A 302108135 302108135A 302108136 302108136A 76178-01; X-COATED ADULT BASIC PACK DOMINICAN REP. 00699753517943 305108959 305108961 305108962 305108963 305108964 306108960 306108965 76273-01; X-COATED FX25RW PACK 00699753507371 249104743 76278; X-COATED FX1540 MASTER PACK 00699753504387 303108139 303108139A 76278-01; X-COATED FX1540 PERFUSION PACK 00699753521957 303111005 303111006 76306; X-COATED VICTORIA FX PACK 00699753505179 0000301082 76308-01; X-COATED FX PUMP & TABLE PACK 00699753517103 0000440647 0000441552 248106055 251107470 302108585 303109527 305110068 306111028 76326-02; X-COATED FX ADULT PACK 00699753508965 0000326852 0000326853 0000455789 76372-01; X-COATED NEONATAL FX PACK 00699753516205 0000455780 249106040 249106059 249107466 301109531 305111798 307111029 76373-01; X-COATED INFANT FX PACK 00699753516144 0000441524 301107467 303110060 303111030 76374-01; X-COATED 3/8 PEDIATRIC FX PACK 00699753516038 244104978 303108589 307114783 76376-01; XC CONGENITAL ADULT FX PACK 00699753517219 0000455766 307111031 76398 DEL NIDO P;K 00699753506602 244104339 303110031 306111095 76427; X-COATED PUMP AND TABLE PACK 00699753507456 245105252 301109206 306114132R 76491-01; X-COATED FX CENTRIFUGAL PUMP PACK 00699753513280 0000439891 0000459156 249106379 307112154 76498; X-C ST CLAIR FX TUBING PACK 00699753508705 0000326849 245105275 250109212 307114543R 76519; X-COATED LAKELAND VSD FX PACK 00699753506091 0000297734 248108416 250109157 303111427 76536 XC HAWAII FX25 LG ADULT PACK 00699753506497 0000322413; 0000441572 0000441659 248105190 248106336 248107187 248107903 249109147 251109780 302110310 305112576 76565; XC HAWAII FX15 SM ADULT PACK 00699753508149 0000326885 0000452194 250105191 251109782 305112579 76575; MERCY X-COATED CONDUCER 00699753506855 0000433587 0000448598 76628 X-CAOTED PUMP PACK 00699753511057 244106372 247108434 76630; HHL/LOURDES 00699753507036 0000324372 250104995 306108175 76635 ; X-COATED ADULT PACK 00699753507234 245106383 250109217 307114535R 7664; X-COATED MIXED PACK 00699753507449 0000326582 76687; X-C LOW PRIME PACK W/CARDIO 00699753507609 0000326850 0000457882 249105255 303110831 76725; ECUADOR X-COATED CPG SET 4:1 AND 1:4 00699753509924 303110010 76732-02; X-C FX ADULT PUMP & TABLE PACK 00699753512856 250998421 251104772 76775; ESSENTIA HEALTH FARGO 00699753508323 0000324377 0000452197 76789; X-COATED PUMP PACK 00699753508279 0000324337 250107916 76832; X-COATED TUBING PACK 00699753510401 0000321900 0000321901 0000324373 0000324374 248106354 248107920 250106355 306111530 76839; XC RIO GRANDE VALLEY PERFUSION 00699753512283 0000450316 302109789 76873-02; X-COATED BAYLOR ALL SAINTS 00699753509788 0000306501 0000453300 0000455803 0000459231 302110340 76878; X-COATED RX PERFUSION PACK 00699753509535 0000450318 247105853 76900; X-COATED PUMP PACK 00699753512481 0000303761 246106380 76999; X-COATED HEART PACK 00699753511774 249104996 77010; X-COATED OPEN SYSTEM FX CUSTOM 00699753510371 0000293006 0000293007 0000293008 0000293009 0000293010 0000293011 0000293012 77012-02; X-COATED CITIZENS VICTORIA FX 00699753514744 244106387 250108392 77014; X-COATED PERFUSION PACK 00699753513044 251107217 77015; XC FX15 HEART AND LUNG PACK 00699753510111 249102139 77105; X-COATED ADULT PACK 00699753511248 0000321904 0000321905 0000445824 245105200 245105798 248107173 250109143 301109192 301110311 302110818 304111415 307114533R 307114534R 77127-01; X-COATED ADULT FX PACK 00699753516076 0000440648 250103289 250105446 303108969 304108583 306109542 307112421 308111818 77227; CPG-FVL 0000444114 307112389 309114447 77299; X-COATED 1/2X3/8 PUMP PACK 00699753512351 0000300327 0000328415 0000450387 244105267 77304; X COATED TUBING PACK 00699753512870 0000326578 0000326579 0000453297 246105203 308113637 77305; XCOATED FX PRESTIGE PACK 00699753513389 0000444094 250103755 302110825 77316-01; X-COATED FPS/PRESCRIPTIVE PACK 00699753517998 248108206 77412; X-COATED SEPARATE LINE ADULT 00699753513709 0000331082 0000441553 0000441650 0000455772 77450; X-COATED LARGE PATIENT PACK 00699753513655 0000441618 77496; X-COATED LEGACY PACK 00699753514669 250109264 77496-01; X-COATED LEGACY PACK 00699753517301 0000440670 248105792 250108826 302110808 77502-01; X-COATED TUBING PACK 00699753414716 0000440677 251107221 77516; BON SECOURS RICHMONDOHOXYCP 00699753514102 0000309054 0000322389 0000322390 244105784 247108415 251109774 302110813 303111441 77521-01; X-COATED AMC PACK 00699753517349 244105794 250108827 251109215 301110301 304110810 307114691R 77532-01; X-COATED ADULT FX PACK 00699753515994 0000455773 246105443 302110065 307111777 77629 ; ADULT PRESTIGE PACK GUATEMALA 00699753515147 251105466 77655-01; X-COATED HEAT LUNG FX PACK 00699753517530 0000440643 246102687 249109193 77722; X-COATED ST VINCENT DEL NIDO 00699753527492 308112342 77742; X-COATED PERFUSION PACK WITH FX25RE 00699753517202 0000441619 301104998 304108176 77757; X-COATED UMBRELLA PACK 00699753515925 247107231 306111756 77791; X-COATED UMC ADULT FX25R HEART 00699753517394 250107911 251108436 77791-01; X-COATED UMC PERFUSION PACK 00699753527485 303111153 77794 X-COATED OXY AND CP PACK 00699753518001 0000459143 304108563 305113024 77796 BAY MEDICAL-PANAMA CITY FL 00699753517448 0000444093 0000450351 78018 X-COATED ADULT PACK DOMINICAN REPUBLIC 00699753528482 0000450280 78027 ADULT SPEC PACK 00699753527881 0000444098 B75409 X-COATED FX15RW40 PACK 00699753497054 243101697 B75410 X-COATED FX25RW PACK 00699753497078 243101699 B75903 X-COATED TRINIDAD FX25 PACK 00699753505216 249106074 249106075 B76178 ADULT BASIC PACK DOMINICAN REP 00699753506664 251108129 302108135 302108136 B76278 X-COATED FX1540 MASTER PACK 00699753506664 303108139", "more_code_info": "" } ] }