Z-0360-2025Class II

URINE KIT, SKU DYKM1845; Component No. 503581

Name: Z-0360-2025 URINE KIT, SKU DYKM1845; Component No. 503581
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-10-23
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-10-23 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of URINE KIT, SKU DYKM1845; Component No. 503581 on 2024-10-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0360-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-23
Posted: 2024-11-12
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: URINE KIT, SKU DYKM1845; Component No. 503581
Product code: LRO General Surgery Tray
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On October 23, 2024, the firm notified customers via Medical Device Recall letters sent through First Class Mail and Email. Customers were informed that the product is actually non-sterile and provided with the full list of impacted convenience kits. Once customers submit the recall response form, they will receive an over-label to place on affected kits, which instruct the user to remove the recalled component. Customers who would like a replacement specimen container may contact their sales representative. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 626,305 Total Kits (US only)
Distribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Product codes and lots: UDI/DI: 40193489713993 (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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0360-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0354-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0355-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0356-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0357-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0358-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0359-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0360-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12
Z-0361-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)