Integra LifeSciences Corp.: Device Recall

Recall #Z-1873-2024 · 04/17/2024

Class II: Risk

Recall Details

Recall Number: Z-1873-2024
Classification: Class II
Product Type: Device
Recalling Firm: Integra LifeSciences Corp.
Status: Ongoing
Date Initiated: 04/17/2024
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,822 units

Reason for Recall

Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

Product Description

Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of CA, BE, CL.

Other Recalls by Integra LifeSciences Corp.

Class II: Risk 02/06/2025

Possibility for the obturator to break (separate).
Class II: Risk 01/10/2025

Potential that the induction seal is not completely sealed to the device tube packaging.
Class II: Risk 12/16/2024

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II: Risk 12/16/2024

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II: Risk 12/16/2024

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

View all recalls by Integra LifeSciences Corp. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.