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Recall Observatory FDA recall evidence

Drug product

BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

D-0243-2026

December 17, 2025

Class II

Product summary

Firm
CareFusion 213, LLC
Event
Event 98142
Status
Ongoing
Classification
Class II
Quantity
106,400 units
Official record key
drug-enforcement:D-0243-2026

Official wording

Reason: Lack of Assurance of Sterlity

Code information: Lot #: 5086623, Exp. Date 03/31/2028

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Lack of Assurance of Sterlity