CLASS II ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to recalled
Integra LifeSciences is recalling Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the, distributed nationwide in the US. The recall was initiated on 19 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1194-2024
- FDA event ID
- 93881
- Recalling firm
- Integra LifeSciences, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Jan 2024
- FDA classified
- 28 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 19 Jan 2024 | Recall initiated by company | |
| 28 Feb 2024 | Classified by FDA | +40 days |
| 6 Mar 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Where it was distributed
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).
Questions about this recall
Is Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the recalled?
Yes. Integra LifeSciences recalled Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the on 19 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1194-2024.
Why was it 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.
Which lots are affected?
UDI: 10381780263869 Lot Number: 7257028 Exp. Date: 1-Jun-24
Where was it sold?
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).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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