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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70603

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

Open FDA event record

Event summary

Timeline bucket
November 08, 2013
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 Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

Z-1259-2015
Recall number
Z-1259-2015
Initiated
November 08, 2013
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
166 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

Code information

Lot Number: KF1111796 Exp. Date: 11/30/2013

Distribution pattern

Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.