Device product
Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
Z-0792-2025
Product summary
- Event
- Event 95852
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2664 units
- Official record key
device-enforcement:Z-0792-2025
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: 1) REF DYNJ47568B, UDI/DI 10193489846058 (EA) 40193489846059 (CS), Lot Numbers: 21EBP877, 21EBP891, 21GBW057, 21GBW059, 21KBG927, 21WBA306, 22ABO417, 22EBE351, 22FBX502, 22FBY332, 22IBJ001, 22LBA177, 23ABD998, 23BBE825, 23CBI861, 23EBO916, 23FBQ324, 23GBN118, 23IBL993, 23JBT331, 23LBC938, 24BBG081, 24BBN421, 24EBC753, 24FBM377, 24HBR212, 24HBS302; 2) REF DYNJ55555D, UDI/DI 23HBQ656; 3) REF DYNJ906448A, UDI/DI 20LBO883, 20WBE707, 21CBS664, 21EBG271.
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.