URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
This recall is currently active, issued November 12, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- October 23, 2024
- Posted
- November 12, 2024
- Recall Number
- Z-0361-2025
- Quantity
- 626,305 Total Kits (US only)
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Lot / Code Info
UDI/DI: 40193489383707 (Case), 10193489383706 (Ea), Lots 22DBP031
Root Cause
Under Investigation by firm
Action Taken
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.