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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72247

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

Open FDA event record

Event summary

Timeline bucket
August 19, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Concentric Medical Inc

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

Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.

Z-0116-2016
Recall number
Z-0116-2016
Initiated
August 19, 2015
Classification
Class II
Status
Terminated
Recalling firm
Concentric Medical Inc
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One Distal Access Catheter intended for distribution in Korea, was found at a US location.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One Distal Access Catheter intended for distribution in Korea, was found at a US location.

Code information

Lot no. 37603 Expiration date: September 2016

Distribution pattern

US Distribution to one location in KY.