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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96879

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 15, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CareFusion 213, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

D-0441-2025
Recall number
D-0441-2025
Initiated
May 15, 2025
Classification
Class II
Status
Ongoing
Recalling firm
CareFusion 213, LLC
Quantity
385,200 applicators

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Code information

Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026

Distribution pattern

Nationwide in the U.S.