Device product
Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
Z-1599-2025
Product summary
- Event
- Event 96510
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 530 units
- Official record key
device-enforcement:Z-1599-2025
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) DYNJ59620A, UDI-DI: 10193489685367(each), 40193489685368(case), Lot Number: 24KBH321; 2) DYND150200S, UDI-DI: 10195327387884(each), 40195327387885(case), Lot Number: 24KBK308
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.