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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80872

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

Open FDA event record

Event summary

Timeline bucket
July 30, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arrow International 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

ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording

Z-3197-2018
Recall number
Z-3197-2018
Initiated
July 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
7 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products are labeled with an incorrect expiration date

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products are labeled with an incorrect expiration date

Code information

Lot/Batch Number:16F18A0010 Use By: 2023-12-31

Distribution pattern

US in the state of PA