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Class 2 Device Recall Cranial Access Kit |
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| Date Initiated by Firm |
April 17, 2024 |
| Date Posted |
May 20, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1873-2024 |
| Recall Event ID |
94453 |
| 510(K)Number |
K961113
|
| Product Classification |
Drills, burrs, trephines & accessories (manual) - Product Code HBG
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| Product |
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure.
Catalog Number: INS5HND |
| Code Information |
UDI-DI: 10381780263906
Lot Number/Exp. Date:
7257032 07/16/2025 ;
7275713 09/03/2025 ;
7291974 09/03/2025;
7312131 09/03/2025;
7289690 09/03/2025;
7291975 09/03/2025;
7312137 09/03/2025
7312139 09/03/2025 |
Recalling Firm/
Manufacturer |
Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
|
| For Additional Information Contact |
Lacey Gigante
609-275-0500
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Manufacturer Reason
for Recall |
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
|
FDA Determined
Cause 2 |
Process control |
| Action |
Integra LifeSciences issued First Notification: Urgent: Voluntary Medical Device Recall Letter delivered by courier service, facsimile or email between April 17th and April 18th, 2024. Letter states reason for recall, health risk and action to take:
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 FCA3@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 and lot number.
9. When the form from you and your customer is received, and it is noted that you or your customer has affected product, Customer Service will contact you or your customer and provide an RMA number and directions to return the product. You can request a credit for the quantities returned.
Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. We recommend you also maintain a copy of this notification and the signed copy of the acknowledgement form for your records.
Should you have any questions regarding these instructions, please contact Customer Service:
Monday to Friday 8:00 AM 8:00 PM EST
USA: 1-800-654-2873: email: custsvcnj@integralife.com
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| Quantity in Commerce |
1,822 units |
| Distribution |
Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
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| 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 and Original Applicant = CLINICAL NEURO SYSTEMS LLC.
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