—#186376

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

FDA product code: HCA — Catheter, Ventricular
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K031123
Affected lot / code info: Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205

Why it was recalled

Incorrect labeling, Catheter did not have the required holes and markings

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: CA CO FL KY MD NC NC NY NY TX WI

Timeline

Recall initiated: 2021-03-17
Posted by FDA: 2021-04-05
Terminated: 2021-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186376. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.