Medline is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels, which may indicate out-of-specification product. Affected kits have specific SKUs and lot numbers listed in the recall.
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.
Medline is recalling medical procedure kits that include Neuro Sponges because internal testing found higher-than-expected endotoxin levels. This could mean the product doesn't meet safety standards for endotoxin levels, which are critical for medical use.
Endotoxins are natural components of bacterial cell walls that can cause infections if they enter the bloodstream. Higher-than-expected levels in the Neuro Sponges could lead to infections if used during medical procedures, but the risk is low because these kits are used in controlled medical environments.
Healthcare professionals and medical facilities that use Medline's VP Shunt procedure kits are likely affected. The risk is low because the issue relates to endotoxin levels, which are typically monitored in medical settings.
Check if your kit has a Medline Neuro Sponge labeled as 'VP SHUNT' with specific SKUs: CDS840193V, CDS982389J, DYNJ0117497G, DYNJ04592K, DYNJ0750993L, DYNJ0753933F, DYNJ39861B, DYNJ39861D, DYNJ44603C, DYNJ56819G, DYNJ61174A, DYNJ68213C, DYNJ68213F, DYNJ84501, or PHS392834010D. Also check the lot numbers listed in the recall.
Verify if your Medline VP Shunt procedure kit contains a Neuro Sponge with the listed SKUs and lot numbers from the recall.
Medline identified higher-than-expected endotoxin levels in a representative Neuro Sponge product during internal testing, indicating the product may be out-of-specification for endotoxin levels.
No, the recall does not require immediate discontinuation. The issue is related to endotoxin levels, which are monitored in medical settings, so the risk is low.
Check the kit's SKU and lot number against the list provided in the recall. Affected kits include specific Medline Neuro Sponge products with SKUs like CDS840193V, CDS982389J, and others, along with the listed lot numbers.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2017-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2017-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
