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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79474

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

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Event summary

Timeline bucket
December 15, 2017
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 ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

Z-1194-2018
Recall number
Z-1194-2018
Initiated
December 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
305

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

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

Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

Code information

Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)

Distribution pattern

Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.