Exact FDA event identifier

Event 91194

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

Event summary

Timeline bucket: November 25, 2022
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

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

D-0076-2023

Recall number: D-0076-2023
Initiated: November 25, 2022
Classification: Class II
Status: Terminated
Recalling firm: B. Braun Medical, Inc.
Quantity: 756 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance: Bags have the potential to leak.

Code information

Lot: 0061832446 Exp. 31 Oct 2024

Distribution pattern

FL, NJ, PA