Z-0173-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2024
- Initiation Date
- September 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51 units
Product Description
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
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