PurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
CareFusion 213, LLC is recalling PurPrep sterile applicators distributed nationwide because unsterilized units intended for further processing were distributed to customers outside the intended channel.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II drug recall. The hazard involves loss of sterility assurance on a topical antiseptic intended for medical procedures, which poses a risk of infection or adverse health consequences if the product is used as intended. Class II recalls with potential for serious health impact meet the Severe criterion.
Plain-English summary
CareFusion 213, LLC is recalling BD PurPrep (Povidone-iodine 8.3% w/w with isopropyl alcohol 72.5% w/w) 50 x 26 mL applicators due to a lack of assurance of sterility. Unsterilized applicators that were intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel.
The product was distributed nationwide in the USA. The affected lot is 4298581, which expires 09/30/2026. The product is a topical antiseptic solution used for skin preparation prior to medical procedures.
Consumers or healthcare facilities that have received PurPrep applicators from lot 4298581 should not use them and should contact CareFusion 213, LLC for instructions on product return or replacement. The loss of sterility assurance means the product may not be suitable for its intended medical use.
The recalled product
- Product
- PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
- Brand
- PURPREP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- lack-of-sterility
- contamination-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 (2)
- Lot: 4298581
- expires: 09/30/2026.
Distribution
Distributed nationwide across the United States.
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