Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89439

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

Open FDA event record

Event summary

Timeline bucket
January 24, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Argon Medical Devices, 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

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

Z-0563-2022
Recall number
Z-0563-2022
Initiated
January 24, 2022
Classification
Class II
Status
Ongoing
Quantity
600 ea

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

Code information

1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026

Distribution pattern

US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.