Integra LifeSciences Corp. Recall: Ref No: INS5HND / Integra Cranial access kit (without P
Integra LifeSciences Corp. Recall: Ref No: INS5HND / Integra Cranial access kit (without P is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Integra LifeSciences Corp.; Product: Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarac
| Recalling firm | Integra LifeSciences Corp. |
|---|---|
| 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 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the). |
| Recall initiated | 20240119 |
| Recall number | Z-1196-2024 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
Try RecallGuard →