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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65584

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

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Event summary

Timeline bucket
December 13, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Riverpoint Medical, LLC

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

Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues

Z-0347-2014
Recall number
Z-0347-2014
Initiated
December 13, 2012
Classification
Class II
Status
Terminated
Recalling firm
Riverpoint Medical, LLC
Quantity
1932 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

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Inspect official wording and provenance

Reason for recall

Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.

Code information

Lot 120716-01

Distribution pattern

US Distribution in the states of: AZ, FL, and TX.