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Integra Cranial Access Kit-For access to the subarachnoid… recallZ-0494-2024 · Integra LifeSciences Corp. · initiated Oct 19, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device

FDA root cause category: Process control

What the company is doing

Integra notified consignees (Hospitals, Government facilities, and Distributors) via Fedex priority overnight on 10/19/23 . Letter titled: 1st Notification- Urgent: Voluntary Medical Device Recall. Letter states reason for recall, health risk and action to take: Actions to be Taken by Customers: 1. If you do have units of the affected product listed in Table 1, remove it immediately from service. 2. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have. 3. If you do not have affected product, check the box, I do not have affected product. 4. Complete the attached Acknowledgement Form and return to [email protected] or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. 6. 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. After completion, please email the Acknowledgement Form to [email protected] or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. 6. Please check your customer traceability records for shipments of above catalog and lot numbers. 7. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. 8. 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 c

Recall details

Recall number
Z-0494-2024
Status
Open, Classified
Initiated by the company
Oct 19, 2023
Posted by the FDA
Dec 6, 2023
Recalling firm
Integra LifeSciences Corp.
Quantity
180 units
Product code
HBG
FDA submissions
K961113
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.

Product description

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280

Code information (models, lots, serial numbers)

UDI-DI:10381780431947 Lot Number/Exp. Date: 6788735 1-Mar-25 7078240 1-May-25

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93356).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page