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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70593

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

Open FDA event record

Event summary

Timeline bucket
February 19, 2015
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 Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

Z-1317-2015
Recall number
Z-1317-2015
Initiated
February 19, 2015
Classification
Class II
Status
Terminated
Quantity
315,800 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.

Code information

Lot #'s 4128925 and 4128926

Distribution pattern

Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.