Z-0791-2025 Class II Ongoing
FDA device recall Z-0791-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on November 21, 2024 and is designated Class II. Reason for recall: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. The recall status is ongoing. Affected quantity: 128 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2025
- Initiation Date
- November 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128 units
Product Description
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
Reason for Recall
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Code Information
UDI/DI 10889942825547 (EA) 40889942825548 (CS), Lot Numbers: 19BKB326, 19DKA892, 19JDA775, 20ADC560