Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra

FDA device recall Z-1195-2024 · posted 2024-02-28 · Open, Classified

Recall details

Recalling firm

Integra LifeSciences Corp.

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.

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

HBG

Quantity affected

23 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

Date initiated

2024-01-19

Date posted

2024-02-28

Location

Princeton, NJ

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