Recall Z-1196-2024— Integra LifeSciences Corp.

Name: FDA recall Z-1196-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-19

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-01-19. It names one FDA 510(k) clearance: K961113. Product: Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.. Reason: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2024-01-19
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

Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

Reason for recall

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

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