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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82015

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

Open FDA event record

Event summary

Timeline bucket
July 03, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott Vascular

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

PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

Z-0960-2019
Recall number
Z-0960-2019
Initiated
July 03, 2018
Classification
Class II
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect expiration being entered for one lot.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect expiration being entered for one lot.

Code information

Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593

Distribution pattern

US Nationwide Distribution - NC and NY