Date Initiated by Firm | December 14, 2020 |
Create Date | December 23, 2020 |
Recall Status1 |
Terminated 3 on July 19, 2021 |
Recall Number | Z-0724-2021 |
Recall Event ID |
86986 |
510(K)Number | K172022 |
Product Classification |
Shunt, central nervous system and components - Product Code JXG
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Product | 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 |
Code Information |
Lot Number: 4178253 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 | 85 units |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JXG
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