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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Cardiovascular Procedure Kits

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  Class 2 Device Recall Terumo Cardiovascular Procedure Kits see related information
Date Initiated by Firm February 20, 2024
Date Posted March 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1401-2024
Recall Event ID 94083
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product 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
Code Information Product Number/Product Name/GTIN/Lot Numbers: 16010 CARDIOPLEGIA SET 4:1 RATIO NO RECIRC 00699753001534 2L05 2L12 2L19 2P19 165720; CARDIOPLEGIA SET 4:1 RATIO16 00699753000278 2K15 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 BRIDGE16 00699753008533 2K15 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 / MP4 00699753458147 2M17 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 FX25RE 00699753529069 0000450368 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 FX25RW 00699753518032 0000440655 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 FX25RE 00699753510098 249107225 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 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
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
Manufacturer 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
FDA Determined
Cause 2		 Process control
Action Terumo issued URGENT Medical Device Safety Alert on 2/20/24 via 2-day FedEx delivery. Letter states reason for recall, health risk and action to take: Do not use the valve included in the kit and discard. The clinician could implement clinical changes such as: 1. Place a stopcock in a closed position or a non-vented cap on the luer lock. 2. Replace the line to the reservoir that has the impacted high pressure check valve in it with another equivalent over-pressure line. The High Crack Check Valve (PN 205307A) is not assembled directly into the finished good and can be replaced with a sterilized over-pressure line. contact Terumo CVS with any questions or concerns: ¿ Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET ¿ Terumo Recall Fax: 732-507-9046 or 732-507-9046@efax.com ¿ Terumo Recall Email: tcvs.recall@terumomedical.com
Quantity in Commerce 20,533 units
Distribution worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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