Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Recalled by Integra LifeSciences Corp. Due to Incorrect labeling, Catheter did not have the required...

Date: March 17, 2021
Company: Integra LifeSciences Corp.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.

Affected Products

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

Quantity: 49 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 9 states: CA, CO, FL, KY, MD, NY, NC, TX, WI

Affected (9 states)Not affected

About Integra LifeSciences Corp.

Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report