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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75350

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

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Event summary

Timeline bucket
September 21, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biocompatibles U.K., Ltd.

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

TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

Z-0078-2017
Recall number
Z-0078-2017
Initiated
September 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biocompatibles U.K., Ltd.
Quantity
64 doses

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect). The product ws labeled as 10 GBq and the actual does was 5 GBq.

Code information

Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)

Distribution pattern

Worldwide Distribution - US to CA, FL, IL, WI, IN, OR, PA, MA, NY, KY, TX, MI, MD, NV, WA, OH, MN, and Internationally to Germany, Turkey, Hong Kong, Italy, Portugal