Device product
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
Z-1590-2025
Product summary
- Event
- Event 96510
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,118 units
- Official record key
device-enforcement:Z-1590-2025
Official wording
Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Code information: 1) DYNJHTCAD1, UDI-DI: 10888277087583(each), 40888277087584(case), Lot Number: 24JBS743; 2) DYNJ05350V, UDI-DI: 10193489316629(each), 40193489316620(case), Lot Number: 24JBU500; 3) DYNJ38144C, UDI-DI: 10193489854916(each), 40193489854917(case), Lot Number: 24KBD294
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Derived failure modes
-
Unknown
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.