Sterile PVP Medical Solution Recalled for Non-Sterile Contents
Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.
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 3/5 (High).
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 medical device recall where a product labeled as 'Sterile' contains non-sterile contents, creating a risk of infection or contamination. No reported illnesses or injuries are mentioned in the source material, making this a risk-of-harm product where injury has not yet been reported, consistent with a High severity classification.
Plain-English summary
Medline Industries, LP is recalling 700 units of Sterile PVP (polyvinylpyrrolidone) solution, Ref DYNDA1649, with lot numbers 2022060190 and 2022021590. The product is identified by UDI/DI 40889942326519 for cases and 10889942326518 for individual units.
The product's labeling includes the word 'Sterile' or 'STRL', but the solution inside the foil sachet is non-sterile. This mismatch between labeling and actual sterility creates a potential contamination risk if the product is used in a clinical or sterile setting where sterile contents are expected.
The affected products were distributed nationwide in Connecticut, Iowa, Louisiana, Massachusetts, Pennsylvania, California, New York, and Florida. Patients and healthcare facilities in these states who have received this product should check their inventory against the lot numbers listed above.
Individuals in possession of affected lots should contact Medline Industries or their healthcare provider for further guidance on proper handling or replacement of the product.
The recalled product
- Product
- STERILE PVP, REF DYNDA1649
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Affected units
- 700
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 40889942326519 (case)
- 10889942326518 (each)
- Lot numbers: 2022060190
- 2022021590
Distribution
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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