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MEDLINE INDUSTRIES, LP – Northfield Recall 95852

Description: Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.

MEDLINE INDUSTRIES, LP – Northfield Recall 95852 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0792-2025
Event ID95852
Event DescriptionMedline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of UAE, and Canada.
Quantity2664 units
Recall ReasonCustom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Device Classification20250108
Device Code Info1) 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.
Center Classification Date20241230
Recall Initiation Date20241121
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Initial Notification Letter
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