Recall Z-1401-2024 ยท OEZ Cardiovascular Procedure Kit
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 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
| Date | Mar 29, 2024 (initiated Feb 20, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | 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 steriliz |
| Quantity | 20,533 units |
| Distribution | worldwide distribution - US Nationwide and the countries of Canada, Chile, Colombia, Mexico, South Korea, Taiwan, Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.