FDAFDA · Food and drugs·Recall number Z-0354-2025
Clean Catch Kit, SKU DYKM1833A; 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: 40193489240697 (Case); 10193489240696 (Ea) Lots: 19LAA531 20BAA260 21KBJ974 22JBK243 22LBJ966 23BBU789 23FBN998 23HBW916 23IBH024 24CBE580 24DBT234 24GBA986 24GBL321
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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