—#204251

Product

STERILE BETADINE, REF DYNDA1998

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI/DI 40889942651062 (case), 10889942651061 (each), Lot numbers: 2023042190, 2022101090, 2022081590, 2022041390, 2022031090, 2022011290, 2021100490

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.

Timeline

Recall initiated: 2023-11-03
Posted by FDA: 2023-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204251. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.