FDAFDA · Food and drugs·Recall number Z-0525-2024
STERILE PVP SOLUTION, REF DYNDA1907
Published December 20, 2023 · Recall initiated: November 3, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
- Lot
- UDI/DI 40889942574491 (case), 10889942574490 (each), Lot numbers: 22LBL675, 22JBR599, 22IBS045, 22GBT655, 22DBN398, 22DBD250, 22DBA001, 21LBN032, 21JBA478, 21EBE405
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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