Reported Nov 20, 2024 · Ongoing

URINE KIT, SKU DYKM1845; Component No. 503581

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?

    • URINE KIT
    • SKU DYKM1845
    • Component No. 503581
Lot codes and dates
  • UDI/DI40193489713993 (Case), 10193489713992 (Ea), Lots
    • 10193489713992
    • 21GMF840
    • 21KMA595
    • 22AMG015
    • 22BMH241
    • 22CMG029
    • 22DMI870
    • 22FMA088
    • 22HMH213
    • 22JMH449
    • 22LMH860
    • 23CMA518
    • 23CMG948
    • 23DMG087
    • 23EMH568
    • 23GMD322
    • 23HME585
    • 23IMG193
    • 23KMD763
    • 24AMD430
    • 24CMA930
    • 24CMD335
    • 24DMA485
    • 24FMF320
    • 24GMJ197
    • 24IME270
Amount recalled
626,305 Total Kits (US only)

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

Why it was recalled

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.