Urine Kit (Medline) – non-sterile specimen container (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
URINE KIT, SKU DYKM1845; Component No. 503581
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
UDI/DI: 40193489713993 (Case), 10193489713992 (Ea)
Products Sold
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
MEDLINE INDUSTRIES, LP Northfield is recalling URINE KIT, SKU DYKM1845; Component No. 503581 due to Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 recalls@medline.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026