Device product
Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
Z-1588-2025
Product summary
- Event
- Event 96510
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-1588-2025
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) DYNJ67577A, UDI-DI: 10193489980349(each), 40193489980340(case), Lot Number: 24JBX252; 2) DYNJ67576A, UDI-DI: 10193489980455(each), 40193489980456(case), Lot Number: 24JBX286
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.