—#204170

Product

Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040

FDA product code: HBG — Drills, Burrs, Trephines & Accessories (Manual)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K961113
Affected lot / code info: UDI-DI: 10381780431909 Lot Number/Exp. Date: 6837706 1-Mar-25

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

Root cause (FDA determination)

Process control

Action the firm took

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 FCA2@integralife.com 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 FCA2@integralife.com 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

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.

Timeline

Recall initiated: 2023-10-19
Posted by FDA: 2023-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204170. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.