Recall Z-0530-2024— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-11-03. FDA's recall record names no specific 510(k) clearance for this event. Product: STERILE BETADINE, REF DYNDA1998. Reason: 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..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-03
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.