Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline Product number/SKU DYNJ53741N; 5) OPEN HEART PACK 1&2, Medline Product number/SKU DYNJ80701A; 6) VEIN PACK, Medline Product number/SKU DYNJ67308C; 7) OPEN HEART PACK, Medline Product number/SKU DYNJ89451B; 8) VASCULAR TRAY-LF, Medline Product number/SKU DYNJ42166A; 9) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363C; 10) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363B; 11) LIVER TRANSPLANT PACK B, Medline Product number/SKU DYNJ65779B; 12) CABG PACK-LF, Medline Product number/SKU DYNJ47661J; 13) VEIN HARVEST PACK, Medline Product number/SKU DYNJ04470L; 14) CARDIAC PACK, Medline Product number/SKU DYNJ44647D; 15) GM OPEN HEART ACC PACK-LF, Medline Product number/SKU DYNJ0660029AM; 16) CARDIOVASCULAR PACK-LF, Medline Product number/SKU DYNJ0160327C; 17) GOOD SHEPHERD OPEN HEART, Medline Product number/SKU DYNJ60819L; 18) OPEN HEART PACK, Medline Product number/SKU DYNJ0271227R; 19) OPEN HEART PACK, Medline Product number/SKU DYNJ81541C; 20) TAVR PACK, Medline Product number/SKU DYNJ54094F; 21) TRANSPLANT BACKTABLE PACK, Medline Product number/SKU DYNJ62055C; 22) VASCULAR, Medline Product number/SKU DYNJ49366; 23) BACK TABLE TRAY, Medline Product number/SKU DYNJ65416D; 24) CV PART 1 AND 2, Medline Product number/SKU DYNJ908879G; 25) OPEN HEART A B PACK, Medline Product number/SKU DYNJ81096B; 26) KIDNEY, Medline Product number/SKU DYNJ54732I; 27) ABDOMINAL PRESEVERVATION PACK, Medline Product number/SKU DYNJ62691F; 28) LIVER PACK SAFETY, Medline Product number/SKU DYNJ54734I; 29) CV PROCEDURE PART A, Medline Product number/SKU DYNJ903745I;
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.