Povidone Solution Labeled Sterile Despite Non-Sterile Contents
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard—non-sterile contents mislabeled as sterile—qualifies as a risk-of-harm medical device product where injury has not yet been reported, fitting Score 3 (High) criteria.
Plain-English summary
Medline Industries, LP (Northfield) is recalling 300 units of Sterile Povidone (Reference DYNDA2061, UDI 40889942697633 for cases and 10889942697632 for individual units), packaged in foil sachets.
The product labeling indicates the contents are 'Sterile' or 'STRL,' but the solution inside the foil sachets has been found to be non-sterile. This mismatch between the label and actual product condition means users may receive material they believe to be sterile when it is not.
The affected lots are 2022040790 and 2022062190, distributed nationwide to facilities in Connecticut, Iowa, Louisiana, Massachusetts, Pennsylvania, California, New York, and Florida.
The FDA classifies this as a Class II recall. No illnesses or injuries have been reported. Healthcare facilities and users should stop using affected units and contact Medline Industries or the FDA for instructions on proper handling.
The recalled product
- Product
- STERILE POVIDONE, REF DYNDA2061
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- mis-labeling
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 40889942697633 (case)
- 10889942697632 (each)
- Lot numbers: 2022040790
- 2022062190
Distribution
Distributed nationwide across the United States.
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