FDAApril 17, 2024device
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
What to do
FDA enforcement status: Ongoing
Brands named
integra lifesciencesintegra
UPCs
103817802639062025731213909
Recall history
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- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
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- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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