FDA-Drug2026-07-08Class IIPROCESSING DEFECT
BD PurPrep povidone-iodine applicators recalled for lack of sterility assurance
What this means
BD PurPrep sterile applicators (povidone-iodine with isopropyl alcohol) were distributed without proper sterilization assurance. Unsterilized applicators intended for further processing were shipped to customers outside the intended distribution channel, affecting Lot 4298581 (expires 09/30/2026).
- Check your facilities for BD PurPrep applicators with Catalog Number 960120NSB and Lot 4298581.
- Do not use applicators from this lot if you received them directly from CareFusion 213, LLC.
- Contact your supplier or BD immediately if you have units from this lot.
- Report any use or adverse events to the FDA MedWatch program or your healthcare provider.
The agency's original wording
Hazard
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
Intended for
All ages
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
N/A
Manufactured in
1550 Northwestern Dr, N/A, El Paso, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0644-2026More CareFusion recalls
- FDA-Drug2026-07-22BD ChloraPrep Clear skin antiseptic recalled for potential sterility packaging defect
- FDA-Drug2026-07-08BD ChloraPrep Clear skin antiseptic recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Scrub Teal recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange skin antiseptic recalled for lack of sterility assurance
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