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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67834

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

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Event summary

Timeline bucket
July 17, 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

Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.

Z-1507-2014
Recall number
Z-1507-2014
Initiated
July 17, 2013
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
170

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM

Code information

lot RF2110924

Distribution pattern

US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.