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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87715

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

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Event summary

Timeline bucket
April 20, 2021
Product types
Drug
Classifications
Class I
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

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 Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-38

D-0373-2021
Recall number
D-0373-2021
Initiated
April 20, 2021
Classification
Class I
Status
Terminated
Recalling firm
CareFusion 213, LLC
Quantity
707,050 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.

Code information

Lot #: 0108186, Exp. 4/30/2023; 0327867, 0327868, 0328213, 0338656, 0339071, 0328947, 0328949, 0329475, 0329477, 0330457, 0330955, 0330606 0333826, 0333852, 0333855, 0334119, 0335787, 0335792, 0335029, 0336506 0336972, 0336051, 0337245, 0337025, 0338653, 0338542, 0338852, 0339892 0339457, Exp. 11/30/2023

Distribution pattern

Nationwide within the United States