—#184976

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

FDA product code: JXG — Shunt, Central Nervous System And Components
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K110751
Affected lot / code info: Lot Number:4178257 Exp. Date: November 2019

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Integra Lifesciences notified consignees (Hospitals and Sales Representatives ) by Urgent Medical Device Recall letter between December 14 and 16, 2020 via courier service, facsimile or email about the initial notification between December 14 and 16, 2020. Letter state reason for recall, health risk and action to take: Customers a. If you do have the affected product in Table 1, remove the product from service. b. Complete the attached acknowledgement form. If you do have affected product, check the box I do have affected product. Record the total quantity of the affected product you have. c. If you do not have affected product, check the box, I do not have affected product. d. Return the completed acknowledgement form to FCA2@integralife.com or FAX to 1-609-750-4220 e. Keep a copy of the form for your records. f. When your form is received, and it is noted that you have the affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the product. A replacement order will also be placed for the quantity noted on the form. Questions regarding these instructions, please contact Customer Service: USA: 800-654-2873 Monday- Friday 8:00AM EST 6:00PM EST custsvcnj@integralife.com

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-12-14
Terminated: 2021-07-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184976. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.