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U.S. Department of Health and Human Services

Class 2 Device Recall CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm

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  Class 2 Device Recall CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm see related information
Date Initiated by Firm March 17, 2021
Date Posted April 05, 2021
Recall Status1 Terminated 3 on December 02, 2021
Recall Number Z-1354-2021
Recall Event ID 87596
510(K)Number K031123  
Product Classification Catheter, ventricular - Product Code HCA
Product CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus.

Catalog Number: NS5524
Code Information Lot Number: 5028205  UDI: (01)10381780526797 (17)210930(10)5028205 
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		 Incorrect labeling, Catheter did not have the required holes and markings
FDA Determined
Cause 2		 Labeling Change Control
Action Integra LifeSciences issued Voluntary Urgent Medical Device Recall letter via courier service, facsimile or email on March 17th for delivery on March 19th, 2021. Letter states reason for recall, health risk and action to take: 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. Receipt of the acknowledgement form ensures that Integra has achieved a level of effectiveness in communicating this information effectively. We recommend you also maintain a copy of this notification and signed copy of the acknowledgement forms for your records. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action. Should you have any 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 49 units
Distribution CA CO FL KY MD NC NC NY NY TX WI
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 = HCA and Original Applicant = Codman & Shurtleff, Inc.
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