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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69464

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

Open FDA event record

Event summary

Timeline bucket
October 08, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Davol, Inc., Subs. C. R. Bard, 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

Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

Z-0191-2015
Recall number
Z-0191-2015
Initiated
October 08, 2014
Classification
Class II
Status
Terminated
Quantity
78 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.

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 patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.

Code information

Lot# HUYD0176

Distribution pattern

US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.