FDAFDA · Food and drugs·Recall number Z-0360-2025
URINE KIT, SKU DYKM1845; 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: 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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