FDAFDA · Food and drugs·Recall number Z-2134-2023
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Published July 19, 2023 · Recall initiated: May 18, 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
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the country of Panama.
- Lot
- UDI/DI (EA) (01)10195327286057, UDI/DI(CS) (01)40195327286058; Lot Numbers: 23EDA775, 23CDB962
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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