Carefusion 213, Llc: Bd Purprep, (povidone-iodine 8.3% W/w (0.83% Available Iodine) With Isopropyl Alcohol 72.5% W/w), 50 X
BD PurPrep Recall Summary BD PurPrep skin antiseptic applicators (povidone-iodine 8.3% with isopropyl alcohol 72.5%) have been recalled because they were not properly sterilized before distribution. The products were intended to be further processed and sterilized by manufacturers, but were instead sent directly to end users in an unsterilized state. This recall affects units distributed nationwide across all U.S. states and territories.
- Recalling firm
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-11
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Distributed Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/cf6ca5e3-0834-430f-8c61-a52fe90641c5