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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96262

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

Open FDA event record

Event summary

Timeline bucket
February 14, 2025
Product types
Drug
Classifications
Class I
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 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.

D-0259-2025
Recall number
D-0259-2025
Initiated
February 14, 2025
Classification
Class I
Status
Ongoing
Recalling firm
CareFusion 213, LLC
Quantity
205,440 applicators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

Code information

Lot #: 3200240, Exp 6/30/2026

Distribution pattern

Nationwide and Canada