Medline Non-Sterile PVP Solution Mislabeled as Sterile Product
Medline Industries recalled 15 units of non-sterile PVP solution in EAR CDS kits that were mislabeled as 'Sterile PVP SLN' instead of 'Non-Sterile PVP Solution, Sterile Packaging.' The mislabeling could result in inappropriate use in sterile medical applications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II labeling error with no reported illnesses or injuries. The mislabeling creates a theoretical risk of inappropriate use in sterile applications, but no actual harm has been documented.
Plain-English summary
Medline Industries, LP has recalled 15 units of non-sterile PVP solution packaged in EAR CDS kits (Model CDS980089O). The affected product lots are 23EBE453 and 23CBW365.
The recalled product was incorrectly labeled as 'Sterile PVP SLN' when it should have been labeled 'Non-Sterile PVP Solution, Sterile Packaging.' This mislabeling could result in users incorrectly believing the solution is sterile, potentially leading to inappropriate use in medical applications requiring sterile solutions.
The product was distributed worldwide, including throughout the United States and Panama. FDA classified this as a Class II recall.
The recalled product
- Product
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 15
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) 10195327303969
- UDI/DI (CS) 40195327303960
- Lot Numbers: 23EBE453
- 23CBW365
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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