Reported Jan 8, 2025 · Ongoing
Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF…
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Medline custom
- medical procedure kits labeled as
1) ENSEMBLE RACHIS-LFREF DYNJ47568B2) UROLOGY ROBOTICREF DYNJ55555D3) KITSPINE LHREF DYNJ906448A
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published DYNJ47568B1019348984605840193489846059UDI/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 DYNJ55555DUDI/DI 23HBQ656 DYNJ906448AUDI/DI 20LBO883, 20WBE707, 21CBS664, 21EBG271. - Amount recalled
- 2664 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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