Exact FDA event identifier

Event 64508

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

Open FDA event record

Event summary

Timeline bucket: February 27, 2013
Product types: Device
Classifications: Class III
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

Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.

Z-1162-2013

Recall number: Z-1162-2013
Initiated: February 27, 2013
Classification: Class III
Status: Terminated
Recalling firm: Sirtex Medical Limited
Quantity: 21 doses

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incorrect expiration date

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect expiration date

Code information

Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10

Distribution pattern

Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV.