Device product
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model Number: DYNJ53032C
Z-1610-2025
Product summary
- Event
- Event 96510
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 354 units
- Official record key
device-enforcement:Z-1610-2025
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) DYNJ41856C, UDI-DI: 10195327429010(each), 40195327429011(case), Lot Number: 24JBM711; 2) DYNJ53032C, UDI-DI: 10195327494094(each), 40195327494095(case), Lot Number: 24JBN788; 3) DYNJ50629M, UDI-DI: 10198459146985(each), 40198459146986(case), Lot Number: 24JBW674; 4) DYNJ40040C, UDI-DI: 10889942683970(each), 40889942683971(case), Lot Number: 24KBC507; 5) DYNJ53032C, UDI-DI: 10195327494094(each), 40195327494095(case), Lot Number: 24KBC655
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.