Exact FDA event identifier

Event 86986

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 14, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Integra LifeSciences Corp.

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

2 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 2

Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073

Z-0724-2021

Recall number: Z-0724-2021
Initiated: December 14, 2020
Classification: Class II
Status: Terminated
Recalling firm: Integra LifeSciences Corp.
Quantity: 85 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa

Code information

Lot Number: 4178253 Exp. Date: November 2019

Distribution pattern

US Nationwide distribution.

device · product 2 of 2

Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087

Z-0725-2021

Recall number: Z-0725-2021
Initiated: December 14, 2020
Classification: Class II
Status: Terminated
Recalling firm: Integra LifeSciences Corp.
Quantity: 17 units