Device product
Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
Z-0154-2025
Product summary
- Event
- Event 95415
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 312 units
- Official record key
device-enforcement:Z-0154-2025
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) DYNJ36320A, UDI/DI 40889942245230 (each), 10889942245239 (case), Lot Numbers: 24ABC836; b) DYNJ41876B, UDI/DI 40193489563086 (each), 10193489563085 (case), Lot Numbers: 23LBM850
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