Z-1610-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 354 units
Product Description
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
Reason for Recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
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