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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90642

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

Open FDA event record

Event summary

Timeline bucket
July 10, 2022
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Intera Oncology, 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

INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.

Z-1522-2022
Recall number
Z-1522-2022
Initiated
July 10, 2022
Classification
Class I
Status
Terminated
Recalling firm
Intera Oncology, Inc.
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Higher than expected flow rate.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Higher than expected flow rate.

Code information

UDI-DI: 00850014110147; Catalogue No. AP03000H; Serial No. 16145, 16151, 16154, 16171, 16177, 16179, 16196, 16201, 16204, 16211, 16212, 16219, 16220, 16235, 16244, 16247, 16260, 16270, 16273, 16298, 16304, 16309, 16313, 16319, 16338, 16346, 16354, 16376, 16379, 16389, 16393, 16394, 16395,16402, 16403, 16405, 16408, 16409, 16411, 16425, 16426, 16428, 16433, 16434, 16437, 16450, 16459, 16461, 16464, 16485.

Distribution pattern

US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.