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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77273

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

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Event summary

Timeline bucket
May 11, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction of a guidewire.

Z-2252-2017
Recall number
Z-2252-2017
Initiated
May 11, 2017
Classification
Class II
Status
Terminated
Quantity
7140 pieces

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
packaging defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.

Code information

11161099 11161729 11160990 11160912

Distribution pattern

Worldwide Distribution - US Nationwide in the countries of Belgium, Canada, Japan, Netherlands