Device product
Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239
Z-1608-2025
Product summary
- Event
- Event 96510
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-1608-2025
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) DYNJCD0239, UDI-DI: 10889942245901(each), 40889942245902(case), Lot Number: 24IBR482
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.