Exact FDA event identifier

Event 91769

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

Event summary

Timeline bucket: March 01, 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

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

Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.

D-0434-2023

Recall number: D-0434-2023
Initiated: March 01, 2023
Classification: Class II
Status: Terminated
Recalling firm: B. Braun Medical Inc
Quantity: 30672

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 Drug: low Anti-Factor IIa potency.

Code information

Lot J2C017; Expiration: 9/30/2023.

Distribution pattern

Nationwide in the USA