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U.S. Department of Health and Human Services

Class 2 Device Recall Bactiseal Endoscopic Ventricular Catheter

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  Class 2 Device Recall Bactiseal Endoscopic Ventricular Catheter see related information
Date Initiated by Firm December 14, 2020
Create Date December 23, 2020
Recall Status1 Terminated 3 on July 19, 2021
Recall Number Z-0725-2021
Recall Event ID 86986
510(K)Number K110751  
Product Classification Shunt, central nervous system and components - Product Code JXG
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
Code Information Lot Number:4178257 Exp. Date: November 2019
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information Contact Lacey Gigante
609-212-9004
Manufacturer Reason
for Recall		 Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
FDA Determined
Cause 2		 Labeling Change Control
Action 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
Quantity in Commerce 17 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JXG and Original Applicant = Codman & Shurtleff, Inc.
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