Exact FDA event identifier

Event 68566

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

Event summary

Timeline bucket: June 13, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

D-1442-2014

Recall number: D-1442-2014
Initiated: June 13, 2013
Classification: Class II
Status: Terminated
Recalling firm: CareFusion 213, LLC
Quantity: 23,000 Applicators

App-derived interpretation

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; Immediate product pouches may not be properly sealed.

Code information

Lot #: 71132, Expiry: 02/2017

Distribution pattern

Nationwide in U.S.