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FDAFDA · Food and drugs·Recall number Z-1401-2024

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

Published April 10, 2024 · Recall initiated: February 20, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Terumo Cardiovascular Systems Corporation
Distributor
worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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