Z-0789-2025 Class II Ongoing
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
- 1494 units
Product Description
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
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
1) REF DYNJ80585A, UDI/DI 10195327063948 (EA) 40195327063949 (CS), Lot Numbers: 22ABF513, 22DBK159, 22DBL699, 22FBQ597; 2) REF DYNJ80585B, UDI/DI 10195327211158 (EA), 40195327211159 (CS), Lot Numbers: 22GBV101, 22HBG177, 22HBU871, 23ABD760, 23BBE037, 23GBL753, 23GBV443, 23HBU815, 23IBJ525, 23JBO457, 23LBD006, 24BBC495, 24CBI323, 24DBJ068, 24DBP653, 24EBP712, 24FBM276, 24IBG473.