Medline Industries, LP: Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
- Reason / hazard
- During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution.
- Recall initiated
- 2026-03-19
- Code info
- UDI/DI EACH 10653160323068, UDI/DI case 40653160323069. Lot Numbers: 23JBY390, 23IBS518, 23FBW067, 23CBO045, 22HBC645, 22GBL079, 22DBP674, 22ABU694, 21IBM298, 21IBM495, 21GBB532, 21EBR576, 21CBL756, 21ABI942, 26ABG606, 25LBS129, 25IBK286, 25GBB222, 25DBH934, 25BBD132, 24LBO080, 24JBW176, 24HBT740, 24EBU727, 24ABW463.
- Product quantity
- 3000 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98664
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