Recall Z-1873-2024— Integra LifeSciences Corp.

Name: FDA recall Z-1873-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-17

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-04-17. It names one FDA 510(k) clearance: K961113. Product: Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND. Reason: Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-17
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILLClinical Neuro Systems, LLC·cleared 1996-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.