Device product
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
Z-0791-2025
Product summary
- Event
- Event 95852
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 128 units
- Official record key
device-enforcement:Z-0791-2025
Official wording
Reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Code information: UDI/DI 10889942825547 (EA) 40889942825548 (CS), Lot Numbers: 19BKB326, 19DKA892, 19JDA775, 20ADC560
Distribution pattern: Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Derived failure modes
-
Unknown
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.