Recall Z-0725-2021— Integra LifeSciences Corp.

Name: FDA recall Z-0725-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-14

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2020-12-14, terminated 2021-07-19. It names one FDA 510(k) clearance: K110751. 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. Reason: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa.

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2020-12-14
Terminated: 2021-07-19
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K110751 — CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETERCodman & Shurtleff, Inc.·cleared 2011-05-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.