Exact FDA event identifier

Event 93174

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

Open FDA event record

Event summary

Timeline bucket: September 26, 2023
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Cordis US Corp

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

Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Z-0286-2024

Recall number: Z-0286-2024
Initiated: September 26, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Cordis US Corp
Quantity: 30 devices

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Non-sterile product labeled as sterile

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

Non-sterile product labeled as sterile was distributed.

Code information

UDI/DI 10705032025935, Lot Number 18223410

Distribution pattern

US Distribution to: OK