Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid spac
Summary
The FDA issued a Class II for Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Gu by Integra LifeSciences Corp.. Reason: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product.
Details
Source
Device Recall
External ID
Z-1196-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI: 10381780263906 Lot Number Exp Date: 7249001 29-Jun-25 7253133 29-Jun-25 7253134 29-Jun-25 7253135 16-Jul-25 7253136 16-Jul-25 7275711 29-Jul-25 7300837 29-Jun-25
Quantity Affected: 1324 units
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.
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).
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-19
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. have FDA actions?
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1196-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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