FDA-Device2024-11-20Class II
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Affected count
626,305 Total Kits (US only)
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0361-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief