Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Reported: May 29, 2024 Initiated: April 17, 2024 #Z-1873-2024
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.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 1,822 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND. Recalled by Integra LifeSciences Corp.. Units affected: 1,822 units.
Why was this product recalled? ▼
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Moderate. Recall number: Z-1873-2024.
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