Exact FDA event identifier

Event 76701

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

Open FDA event record

Event summary

Timeline bucket: November 11, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Greatbatch Medical

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

ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

Z-2781-2017

Recall number: Z-2781-2017
Initiated: November 11, 2016
Classification: Class II
Status: Terminated
Recalling firm: Greatbatch Medical
Quantity: 5,000 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

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

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

Code information

Lot Number: W3101005

Distribution pattern

NY