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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90824

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

Open FDA event record

Event summary

Timeline bucket
September 15, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Becton Dickinson & Company

Dossier provenance

Source snapshots represented here

  • openFDA Device 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.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

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.

device · product 1 of 1

BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.

Z-0095-2023
Recall number
Z-0095-2023
Initiated
September 15, 2022
Classification
Class II
Status
Ongoing
Quantity
2,196,000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.

Code information

UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.

Distribution pattern

Distribution US nationwide, Canada, New Zealand, and Hong Kong.