STERILE BETADINE, REF DYNDA1998
This recall is currently active, issued December 11, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 3, 2023
- Posted
- December 11, 2023
- Recall Number
- Z-0530-2024
- Quantity
- 1800 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Lot / Code Info
UDI/DI 40889942651062 (case), 10889942651061 (each), Lot numbers: 2023042190, 2022101090, 2022081590, 2022041390, 2022031090, 2022011290, 2021100490
Root Cause
Under Investigation by firm
Action Taken
Medline Industries notified its consignees on 11/03/2023 via by email and US Mail (first class). The notice explained the issue and requested the destruction of any affected inventory. Distributor were directed to notify their customers.