STERILE PVP SOLUTION, REF DYNDA1907
FDA Recall Z-0525-2024 · Posted 2023-12-11
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeOFF
Date Initiated2023-11-03
Product Quantity8250 units
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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.