| Class 2 Device Recall Integra Cranial Access Kit | |
Date Initiated by Firm | January 19, 2024 |
Date Posted | February 28, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1197-2024 |
Recall Event ID |
93881 |
510(K)Number | K961113 |
Product Classification |
Drills, burrs, trephines & accessories (manual) - Product Code HBG
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Product | Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. |
Code Information |
UDI:10381780431916
Lot Number: 7124718
Exp Date: 1-Sep-24
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Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 1100 Campus Rd Princeton NJ 08540-6650
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For Additional Information Contact | Lacey Gigante 609-275-0500 |
Manufacturer 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. |
FDA Determined Cause 2 | Process control |
Action | Integra issued 1st Notification- Urgent: Voluntary Medical Device Recall letter on 01/19/24 via fedex overnight. Letter states reason for recall, health risk and action to take:
1. If you do have units of the affected product listed in Table 1, remove them immediately from service and quarantine.
2. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the total quantity of the affected product that you have.
3. Forward this notice to those who utilize the device so they are aware of this recall and can identify any affected devices that may remain in clinical areas.
4. If you do not have affected product, check the box, I do not have affected product.
5. Complete the rest of the Acknowledgement Form and return to FCA1@integralife.com or FAX to 1-609-750-4220.
6. Keep a copy of the form for your records.
7. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit or a replacement for the quantities returned (based on inventory availability).
Actions to be Taken by Distributors/Sales Reps:
1. If you do have the affected product listed in Table 1, remove the product from further distribution.
2. Complete the attached Acknowledgment Form.
3. If you do have affected product, check the box I do have affected product. Record the total quantity of affected product you have.
4. If you do not have affected product, check the box, I do not have affected product.
5. After completion, please email the Acknowledgement Form to FCA1@integralife.com or FAX to 1-609-750-4220.
6. Keep a copy of the form for your records.
7. Please check your customer traceability records for shipments of above catalog and lot numbers.
8. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog |
Quantity in Commerce | 188 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). |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = HBG
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