Recall Z-2132-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-2132-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-18

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O. Reason: Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING"..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-05-18
Firm location: Northfield, IL, United States

Product description

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O

Reason for recall

Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

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