Reported Nov 20, 2024 · Ongoing

URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; 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 COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
Lot codes and dates

6 of 6 products

Products covered by this recall
Model / numberBarcodesProduct as published
DYKM1848A4019348922814510193489228144UDI/DI: 40193489228145 (Case), 10193489228144 (Ea) - Lots: 19LAA062 19LAA679 19LAB089 20AAA248 20AAA946
DYKM20054019348947554910193489475548UDI/DI: 40193489475549 (Case), 10193489475548 (Ea) - Lots: 21ABL580 21DBG554 21JBC048 21JBE414 21JBM540 21KBK233 21LBJ354 21LBJ398
DYKM21514019532713212610195327132125UDI/DI: 40195327132126 (Case), 10195327132125 (Ea) - Lots: 24EMG654 24IMA511
DYLAB1004A40193489438223101934894382224019532721668010195327216689SKU DYLAB1004 - UDI-DI: 40193489438223 (Case), 10193489438222 (Ea) - Lots: 20KBQ534 21ABL545 21IBC805 21JBN917 21JBX167 21KBN889 - UDI/DI: 40195327216680 (Case), 10195327216689 (Ea) - Lots: 22GMH357 22IMG479
DYLAB10064019348986357510193489863574UDI/DI: 40193489863575 (Case), 10193489863574 (Ea) - Lots: 21DBP497 21ELA493 21FLA001 21FLA001Z 21GLA397 21GLA835 22DLA811 22DLA903 22ELA725 22ELA923 22GLB140 22HLA173 22HLA458 22HLB334 22KLA089 22KLA161 23ALA267 23ALA943 23ALA960 23BLA520 23DLA028 23DLA896 23ELA259 23ELA755 23GLA515 23HLA543 23KLA012 24ALA101 24ALA799 24BLA337 24DLA479 24ELA438 24FLA307 24GLA156 24HLA576 24HLA989 24ILA230
DYLAB10124019532704412210195327044121UDI/DI: 40195327044122 (Case), 10195327044121 (Ea) - Lots: 21LBR785 22BBG465 22EBU527 22FBC688 22JBK244 22KBG840 22LBB361 23CBH872 23CBP152 23EBF399 23GBC712 23HBQ555 23IBT131 23KBK764 24ABG515 24CBH845 24CBP719 24DBJ359 24EBR584 24HBK276 24IBJ812
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, 5:38 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.