Reported Dec 30, 2020 · Terminated
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- Bactiseal Ventricular Catheter with
- Bactiseal Shunt System - Product Usageuse in the treatment of hydrocephalus as a component of a shunt system when draining or shunting
- cerebrospinal fluid (CSF) Part Number823073
- Lot codes and dates
- Lot Number4178253 Exp
- DateNovember 2019
- Amount recalled
- 85 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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