Exact FDA event identifier

Event 73376

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

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Event summary

Timeline bucket: February 17, 2016
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

ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Z-1029-2016

Recall number: Z-1029-2016
Initiated: February 17, 2016
Classification: Class II
Status: Terminated
Recalling firm: Argon Medical Devices, Inc
Quantity: 2000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.

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

The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.

Code information

Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)

Distribution pattern

Distributed in IL.