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CLASS II · ModerateFDA

CareFusion 213, LLC recalls BD PurPrep

📅 Jun 11, 2026 · 📍 Nationwide
Recalling company
CareFusion 213, LLC
Product
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.
Reason
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jun 11, 2026
Reported
Jul 8, 2026
Distribution
Distributed Nationwide in the USA
Status
Ongoing
Quantity
N/A
Lot / codes
Lot: 4298581, expires: 09/30/2026.
Company location
El Paso, TX
Recall type
Voluntary: Firm initiated
Recall number
D-0644-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0644-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.