Reported Nov 20, 2024 · Ongoing

UA KIT, SKU DYKM1690A; 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?

    • UA KIT
    • SKU DYKM1690A
    • Component No. 503581
Lot codes and dates
  • UDI-DI
    • 40193489744201 (Case)
    • 10193489744200 (Ea)
  • Lots
    • 19KAA457
    • 19LAB178
    • 20FAB341
    • 20IAA286
    • 20WBC414
    • 21CBK056
    • 21EBG180
    • 21HBC490
    • 21KBB192
    • 22ABJ687
    • 22DBO057
    • 22GBO519
    • 22IBB016
    • 22LBC924
    • 23BBN989
    • 23EBF212
    • 23GBA753
    • 23IBD142
    • 23LBJ724
    • 24BBI191
    • 24FBC575
    • 24GBX259
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, 6:55 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.