Ref No: HITHSP04 / Integra Cranial Access Kit. For recall: Sterility Concern
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Why was Ref No: HITHSP04 / Integra Cranial Access Kit. For 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: 10381780263869 Lot Number: 7257028 Exp. Date: 1-Jun-24
- Product
- Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 27 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)