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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65322

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

Open FDA event record

Event summary

Timeline bucket
May 01, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
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 Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.

Z-1923-2013
Recall number
Z-1923-2013
Initiated
May 01, 2013
Classification
Class II
Status
Terminated
Quantity
37,906,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.

Code information

Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380.

Distribution pattern

Nationwide Distribution