Terumo Cardiovascular Systems Corporation: Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74

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

Details from the source

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 Distribution: worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand. Quantity: 20,533 units Lot/code info: 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

UPC codes

00699753001534, 00699753000278, 00699753454880, 00699753008533, 00699753497092, 00699753517233, 00699753499348, 00699753458147, 00699753500808, 00699753485297, 00699753487833, 00699753510548, 00699753489202, 00699753491533, 00699753493261, 00699753529069, 00699753509344, 00699753513716, 00699753492615, 00699753510265, 00699753507319, 00699753461970, 00699753515789, 00699753507180, 00699753507197, 00699753513815, 00699753508262, 00699753501454, 00699753501515, 00699753490079, 00699753484610, 00699753483248, 00699753505964, 00699753484627, 00699753512863, 00699753516168, 00699753505797, 00699753479227, 00699753512917, 00699753516090

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.