Reported Apr 10, 2024 · Ongoing

Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312…

Terumo Cardiovascular Systems Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586

Is this the product you have?

  • Cardiovascular Procedure Kits that include High Crack
  • Check Valve PN 205307A Part Number

    171 of 171 codes

    • 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
Lot codes and dates

9 of 9 products

Products covered by this recall
Model / numberBarcodesProduct as published
RATIO16006997530002782K15 2K22 2K29 2L05 2L19 2L26 2M03 2M10 2P19 3A02 62974; CUSTOM CP50 4:1 CARDIOPLEGIA 00699753454880 0000321897 245106371 302110840 6375; CARDIOPLEGIA SET 4:1 RATIO WITH
BRIDGE16006997530085332K15 2K22 2L12 2L19 2L26 2P19 65046-03; PUMP AND TABLE PACK 00699753497092 0000311775 0000311776 243105334 65080-06; ADULT-SSOCIAL-EL SALVADOR PAC 00699753517233 0000452207 65167-06; PUMP & TABLE FX PACK 00699753499348 0000329322 0000329331 0000447522 301104985 303108168 65246; CUSTOM 1:1 CONDUCER /
MP4006997534581472M17 2P12 65934-01; UCSD PTE CARDIOFLEX CP 1:4/4:1 00699753500808 0000288968 0000437413 0000452200 242102098 243105189 243105789 246107180 249109155 251109777 65940-01; UCSF ADULT PACK 00699753485297 0000328414 0000331083 243105281 246105282 250107937 66041-01; VAMC SF TUBING PACK 00699753487833 0000329895 66154-01; PED CPG BT MUF LINE 00699753510548 303110004 66312; 4:1 CARDIOPLEGIA SET 00699753489202 0000324255 242103295 249107463 308111832 66342; RX15 NON X-COATED PACK 00699753491533 0000306497 0000306498 0000306499 248105327 301108454 302110899 66388; RX25 NON X-COATED PACK 00699753493261 0000320596 0000329321 66503-02; ADULT PACK ROSALES
FX25RE006997535290690000450368 66650; CARDIOPLEGIA 00699753509344 251108577 304110009 304112395 66852; CPG DEL NIDO PANAMA 00699753513716 243999665 246105460 251108579 308112349 70148-02; TOTAL VISION SYSTEM 00699753492615 0000309898 0000440663 302110835 70178-06; AR CHILDRENS HYPO/INFANT SET 00699753510265 0000444141 0000457866 70188-05; UVRMC MEMBRANE PACK 00699753507319 0000306512 0000306513 0000441631 0000450286 250109165 251107206 302110344 70472; COATED CUSTOM INFANT PACK 00699753461970 0000439896 70638-07; COMMUNITY OH 4:1 CARDIO CEN 00699753515789 0000324364 0000440665 0000457895 250107193 251109771 302110814 303111435 70664-02 ; PRESTIGE PACK 00699753507180 307114008 307114219 70665-01; PERFUSION PACK 00699753507197 0000321902 0000321903 305110370 70734-03; X-COATED PRESTIGE PACK 00699753513815 245104987 306109545 306114105R 71064-01; NEONATAL PACK 00699753508262 0000326891 0000326892 0000450287 71432-02; X-COATED FX NEONATE PACK 00699753501454 0000321878 0000324346 308114486 71433-01; FX PEDIATRIC PACK WITH NO OXY 00699753501515 0000328612 71546-02; VAMC-SAN ANTONIO 00699753490079 249107214 71733-02; UT PERFUSION TUBING PACK 00699753484610 0000301072 0000301073 0000301074 0000303749 0000317609 0000317610 0000450374 0000450378 245104762 248106367 249106368 251107869 305112155 71754-04; ANNS X-COATED FX PACK 00699753483248 0000453295 302105248 71801-02; X-COATED ADULT PACK 00699753505964 0000307712 0000307713 0000307714 0000307715 0000440660 0000440675 0000450379 0000450380 0000453315 0000453316 248108420 301109196 302110321 71820-01; VAMC PERFUSION TUBING PACK 00699753484627 0000303747 0000303748 245106538 71928-06; CUSTOM X-COATED FX SMALL ADULT PACK 00699753512863 245104799 71934-04; X-COATED PERFUSION PACK 00699753516168 0000441622 250108164 305112783 306111058 72073-02; X-C PUMP & TABLE PACK WITH CP 00699753505797 0000326887 245103302 250105485 307111018 72149-01; LAFAYETTE PERFUSION PACK 00699753479227 0000326890 0000331118 0000447525 248103303 248105486 303108169 72226-06; CUSTOM X-C INFANT 1/4 X 1/4 BABY FX PACK 00699753512917 244104742 72326-07; ROCKINGHAMOH W/1/2"VENOUSCP 00699753516090 0000450283 243105199 247108406 249109151 73008-02; X-COATED PUMP AND TABLE PACK 00699753516182 0000309060 73346-01; X-COATED PUMP AND TABLE PACK WITH
FX25RW006997535180320000440655 250108636 73567-01; MEMORIAL HERMAN SMALL 00699753481664 0000453291 0000453331 73568-01; MEMORIAL HERMAN LARGE 00699753481657 304111470 73776-04; X-COATED PRESTIGE PACK 00699753515598 0000329893 0000329894 250107924 73783-02; X-COATED SMALL ADULT PACK 00699753516243 0000363564 0000450367 301110283 73882-03; SALEMOHNO OXYCARDIO 00699753517431 0000450369 302108414 303111422 74172-03; X-COATED PERFUSION TUBING PACK 00699753516113 306112132 306113046 74307; SCRIPPS CEREBRAL PERFUSION PK 00699753486669 0000448562 74365; U OF M 3/8 X 3/8 ADULT PACK 00699753484696 0000309896 0000450384 302110850 74366; U OF M 3/8 X 1/2 ADULT PACK 00699753484702 0000303782 0000303783 0000303784 0000307711 0000439909 245105292 248105293 248107923 250109231 303110884 74430; X-COATED PUMP PACK W/DELPHIN 00699753489974 0000310922 0000310923 0000310924 0000321877 0000324345 245105849 248106566 251108832 302110341 304112138 74475; X-COATED NEONATE PACK 00699753493520 0000326846 0000455782 243104974 249107455 301109528 305111032 74477; X-COATED ADULT PACK 00699753493544 0000448578 0000455771 74502; SANFORD XC FX PERFUSION PK 00699753487970 0000322412 250109166 307112623 74685-01; AIKEN-OH CARDIO 4:1 HEMOCONC 00699753515697 245106345 74734-01; X-COATED FX25 HEART LUNG PACK 00699753490109 301104991 304108170 306111059 74773; TERUMO LATIN AMERICA 00699753490314 246107286 308112362 74833-01; HCG-CARDIOPLEGIA 00699753517400 246105001 74873; SANFORD XC SMALL PERF PACK 00699753490178 249107928 307112143 74879-07; HARRISBURG-1:4 PLEGIA XC 00699753517509 0000444101 0000453304 244106346 250108828 251109770 302110809 305112573 74921-02; ST LUKE'S HOSPITAL 00699753499188 0000453299 250105289 304105810 74965-03; X-COATED HEART PACK 00699753499966 0000300333 0000300334 0000300335 247105303 247107932 249107219 74965-04; X-COATED FX HEART PACK 00699753529076 0000440668 0000459155 74972-01; XC P&T PRESTIGE PK W
FX25RE00699753510098249107225 75030-01; X-COATED FX PACK 00699753503076 0000322984 75050-02; X-COATED PERFUSION PK W 1:4 CP 00699753512405 246106397 75065; XC PRESCRIPTIVE PERF PACK 00699753493858 0000303785 0000303786 0000303787 0000309055 0000309056 245104840 248107265 251107945 304110895 75068-01; RWJ X-COATED PRES OXY PACK 00699753503021 0000324347 0000330691 0000447529 0000453301 0000459228 244104822 247105313 250107943 75157; MORRISTOWN 1:4 CP50 CARDIOPLEG 00699753493728 0000326833 0000326870 0000440666 0000441573 246108411 248109144 251109765 305112577 75159-01; X-COATED RIO PERFUSION PACK 00699753499485 0000322394 306112153 75195; CENTRAL MAINE 00699753494640 0000326872 246107229 75293-01; 1:4 CARDIOPLEGIA PACK 00699753515185 244105866 75409; X-COATED FX15RW40 PACK 00699753497061 243101697 75409-01; X-COATED FX15RW40 PACK 00699753516137 244104993 75409-02; X-COATED FX15RW40 PACK 00699753517714 303109546 307112346 308110576 75410; X-COATED FX25RW PACK 00699753497085 243101699 75410-01; X-COATED FX25RW PACK 00699753516120 245104994 307114541R 75410-02; X-COATED FX25RW PACK 00699753517721 303109547 307112347 308110577 75473; DSA/CP FX PACK 00699753497740 0000326884 251103305 302105488 305111065 75533; MOTT NEONATE DEL NIDEO PACK 00699753498990 0000440664 75534; MOTT INFANT DEL NIDO PACK 00699753498969 0000453294 75540-03 ; WASHINGTON HOSPFX OXY CARDI 00699753515024 243105195 246107185 75540-05; WASHINGTON HOSP FX OXY CARD 00699753528741 0000441561 75572-01; X-COATED PERSCRIPTIVE FX PACK 00699753504516 0000331079 0000445810 245100846 245102576 75607; X-COATED PERFUSION PACK 00699753499980 0000330335 0000450310 75642-02; HEME X-COATED TUBING PACK 00699753504110 0000289021 0000289024 0000324348 0000324349 246106384 304110829 75688-01; X-COATED FX PRESCRIPTIVE PACK 00699753501782 0000457906 75765; X-COATED PEDIATRIC PACK 00699753507593 301108396 75790-02; X-COATED FX PACK WITH
CP50006997535174240000439904 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-COAT006997535048130000326843 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
FX25RE006997535172020000441619 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
Amount recalled
20,533 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.