Exact FDA event identifier

Event 69535

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

Open FDA event record

Event summary

Timeline bucket: September 18, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Dokitz NovoSci

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

Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014

Z-0178-2015

Recall number: Z-0178-2015
Initiated: September 18, 2014
Classification: Class II
Status: Terminated
Recalling firm: Dokitz NovoSci
Quantity: 240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The single leg of the PAY connector has been observed to become detached.

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

The single leg of the PAY connector has been observed to become detached.

Code information

Model No. 321334-000, lot number 295424

Distribution pattern

MO, TX, PA, IL, MD, UT