FDAFDA · Food and drugs·Recall number Z-0361-2025
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
Published November 20, 2024 · Recall initiated: October 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
- Lot
- UDI/DI: 40193489383707 (Case), 10193489383706 (Ea), Lots 22DBP031
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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