Recall Z-1873-2024 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
Integra LifeSciences Corp.
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
| Date | May 20, 2024 (initiated Apr 17, 2024) |
| Status | Open, Classified |
| Reason | Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device. |
| Root cause | 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 no |
| Quantity | 1,822 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of CA, BE, CL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL Clinical Neuro Systems, LLC, Jun 5, 1996 |