Medline Non-Sterile PVP Solution Mislabeled as Sterile
Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a labeling defect on a medical device (FDA Class II) where a non-sterile product was mislabeled as sterile. While no illnesses or injuries have been reported, the mislabeling poses a clear risk of harm—using a non-sterile solution in sterile contexts could cause infection. This qualifies as a risk-of-harm product without reported injury.
Plain-English summary
Medline Industries, LP is recalling MEDLINE NON-STERILE PVP SOLUTION packaged in kits as OISC HAND BEAR (Model Number DYNJ902348L). The affected product lots were mislabeled as 'STERILE PVP SLN' when they should have been labeled 'NON-STERILE PVP SOLUTION, STERILE PACKAGING'.
The mislabeling creates a risk that healthcare facilities or users could apply a non-sterile solution in contexts where sterile application is required, potentially introducing contamination and infection risk.
Affected lots are: 23EDA775 and 23CDB962. The product was distributed worldwide, including throughout the US and Panama. The recall involves 128 units total.
If you have received this product, do not use it as a sterile solution. Contact Medline Industries with questions about replacement or return of affected units.
The recalled product
- Product
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- mislabeling
- sterile-non-sterile-confusion
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI (EA) (01)10195327286057
- UDI/DI(CS) (01)40195327286058
- Lot Numbers: 23EDA775
- 23CDB962
Distribution
Distributed nationwide across the United States.
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