Exact FDA event identifier

Event 88112

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

Open FDA event record

Event summary

Timeline bucket: June 09, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Cordis Corporation

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

Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Z-2079-2021

Recall number: Z-2079-2021
Initiated: June 09, 2021
Classification: Class II
Status: Terminated
Recalling firm: Cordis Corporation
Quantity: 680 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

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

The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

Code information

Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.