Exact FDA event identifier

Event 79193

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

Open FDA event record

Event summary

Timeline bucket: September 22, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Angiodynamics, 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

Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Z-0742-2018

Recall number: Z-0742-2018
Initiated: September 22, 2017
Classification: Class II
Status: Terminated
Recalling firm: Angiodynamics, Inc.
Quantity: 28

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product was placed into distribution prior to completion of all required post sterilization release activities.

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

Product was placed into distribution prior to completion of all required post sterilization release activities.

Code information

Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20

Distribution pattern

US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.