CareFusion 213: Multiple Chlorhexidine Gluconate Solutions
BD recalls ChloraPrep Clear and FREPP Clear applicators due to sterility seal breach risk.
Stop using the recalled ChloraPrep applicators immediately. Check your inventory for the affected NDC 54365-400-31 and contact BD for instructions on returning the product and obtaining a replacement or refund.
Why it was recalled
BD is recalling ChloraPrep Clear and ChloraPrep FREPP Clear antiseptic applicators (1 mL, 60-count) because wrinkles in the paper lidding may breach the seal, compromising sterility. The affected products include 2% chlorhexidine gluconate and 70% isopropyl alcohol applicators.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Lot code | Best-by | NDC | Catalog (Ref) Number |
|---|---|---|---|---|
| BD ChloraPrep™ Clear - 1 mL Applicators | 4032183 | 01/31/2027 | 54365-400-31 | 930480 |
| BD ChloraPrep™ FREPP™ Clear 1.5 mL Applicators | 4073005 | 03/31/2027 | 54365-400-30 | 930299 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Other recent recalls from CareFusion 213, LLC
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification