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
Reported: December 30, 2020 Initiated: December 14, 2020 #Z-0724-2021
Product Description
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
Reason for Recall
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 85 units
- Distribution
- US Nationwide distribution.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Integra LifeSciences Corp.. Units affected: 85 units.
Why was this product recalled? ▼
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0724-2021.
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