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

Recall Z-1197-2024 — Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

U.S. FDA — Device Enforcement · United States · 2024-01-19 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1197-2024
Date of alert
2024-01-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Integra LifeSciences Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10381780431916
Reported risk: 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.
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.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.