UA Kit (Medline) – non-sterile specimen container (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
UA KIT, SKU DYKM1690A; Component No. 503581
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
UDI-DI: 40193489744201 (Case)
Products Sold
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
MEDLINE INDUSTRIES, LP Northfield is recalling UA KIT, SKU DYKM1690A; 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