Exact FDA event identifier

Event 87393

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

Open FDA event record

Event summary

Timeline bucket: February 22, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sirtex Medical Limited

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

SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

Z-1275-2021

Recall number: Z-1275-2021
Initiated: February 22, 2021
Classification: Class II
Status: Terminated
Recalling firm: Sirtex Medical Limited
Quantity: 3310

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential presence of particulate matter in the D-Vial.

Code information

Lot Numbers: 1031234, 1031225, 1031227, 1031229

Distribution pattern

US Nationwide distribution.