PlainRecalls
FDA Devices Moderate Class II Ongoing

STERILE BETADINE, REF DYNDA1998

Reported: December 20, 2023 Initiated: November 3, 2023 #Z-0530-2024

Product Description

STERILE BETADINE, REF DYNDA1998

Reason for Recall

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

Details

Units Affected
1800 units
Distribution
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
STERILE BETADINE, REF DYNDA1998. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 1800 units.
Why was this product recalled?
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 20, 2023. Severity: Moderate. Recall number: Z-0530-2024.