Ref No: INSHITHND / Integra¿ Cranial access kit recall: Sterility Concern
Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles…
Why was Ref No: INSHITHND / Integra¿ Cranial access kit recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 10381780263975 Lot Number Exp: Date: 6710227 30-Jun-24 6788602 30-Jun-24 6955170 7-Feb-25 7000268 7-Feb-05 7028247 10-Apr-25 7078234 11-May-25 7249010 18-Jul-25 7253163 22-Jun-25
- Product
- Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 915 units
- 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 date
- March 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)