FDAFDA · Food and drugs·Recall number Z-0792-2025
Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
Published January 8, 2025 · Recall initiated: November 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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