Recall Z-0354-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0354-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-23

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Clean Catch Kit, SKU DYKM1833A; Component No. 503581. Reason: 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..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-10-23
Firm location: Northfield, IL, United States

Product description

Clean Catch Kit, SKU DYKM1833A; Component No. 503581

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.