Class II

Medical Device Recall: UA KIT, SKU DYKM1690A; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield · October 23, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

626,305 Total Kits (US only)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0356-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.