Urine Kit, Sku Dykm1845 recallZ-0360-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Oct 23, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-0360-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 23, 2024
- Posted by the FDA
- Nov 12, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 626,305 Total Kits (US only)
- Product code
- LRO
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Product description
URINE KIT, SKU DYKM1845; Component No. 503581
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYKM1845Medline Industries, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95628).
- Z-0354-2025 · Open, ClassifiedClean Catch Kit, SKU DYKM1833A; Component No. 503581
- Z-0355-2025 · Open, ClassifiedLab Kit, SKU DYLAB1018; Component No. 503581
- Z-0356-2025 · Open, ClassifiedUA KIT, SKU DYKM1690A; Component No. 503581
- Z-0357-2025 · Open, ClassifiedURINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
- Z-0358-2025 · Open, ClassifiedURINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
- Z-0359-2025 · Open, ClassifiedURINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
- Z-0361-2025 · Open, ClassifiedURINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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