Device product
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
Z-0173-2025
Product summary
- Event
- Event 95415
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 51 units
- Official record key
device-enforcement:Z-0173-2025
Official wording
Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Code information: a) REF DYNJ37909A, UDI/DI 40193489675451 (each), 10193489675450 (case), Lot Numbers: 24ABG035; b) REF DYNJ40040C, UDI/DI 40889942683971 (each), 10889942683970 (case), Lot Numbers: 23KBB863
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Derived failure modes
-
Sterility assurance
sterile product if the vendor seal of the pouch is opened/unsealed