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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92292

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

Open FDA event record

Event summary

Timeline bucket
May 09, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
B. Braun Medical Inc

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

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,

D-0579-2023
Recall number
D-0579-2023
Initiated
May 09, 2023
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical Inc
Quantity
1,380

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent: Low anti-factor IIa Potency.

Code information

Lot Number: J1P154N, Exp: 31 May, 2023,

Distribution pattern

Nationwide in the USA