FDAClass IIDecember 30, 2020

Bactiseal Ventricular Catheter with Bactiseal Shunt recall: Labeling Error

Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system…

Why was Bactiseal Ventricular Catheter with Bactiseal Shunt recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 4178253 Exp. Date: November 2019

Product
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system…
Recalling firm
Integra LifeSciences Corp.
Quantity
85 units
Distribution
US Nationwide distribution.
Recall date
December 30, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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