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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81665

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

Open FDA event record

Event summary

Timeline bucket
November 14, 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 CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products

Z-0723-2019
Recall number
Z-0723-2019
Initiated
November 14, 2018
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
15 in the US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The lidstock states the incorrect priming volume and flow rates.

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

The lidstock states the incorrect priming volume and flow rates.

Code information

Lots 14F18F0336 & 14F18E0121

Distribution pattern

Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru.