Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0495-2024 — Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260

U.S. FDA — Device Enforcement · United States · 2023-10-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0495-2024
Date of alert
2023-10-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Integra LifeSciences Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10381780431923
Reported risk: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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