The Recall Desk

FDA (Devices) recall action 86986

Integra LifeSciences Corp. recalled 2 products on 2020-12-30

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-12-30
Critical
0
Units
102

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2020-12-30

    Integra Recalls Mislabeled Bactiseal Endoscopic Ventricular Catheters

    Integra LifeSciences is recalling 17 Bactiseal Endoscopic Ventricular Catheters due to mislabeling. The devices were incorrectly identified as a different catheter model.

    Product
    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
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-12-30

    Integra Recalls Mislabeled Bactiseal Ventricular Catheters for Hydrocephalus Treatment

    Integra LifeSciences is recalling 85 units of Bactiseal Ventricular Catheters that were mislabeled as Endoscopic Ventricular Catheters. The error involves swapped product labels for part numbers 823073 and 823087.

    Product
    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
    Category
    Distribution
    0 states