Recall Z-2171-2011 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
Integra LifeSciences Corp.
Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection.
| Date | May 10, 2011 (initiated Feb 22, 2011) |
| Status | Terminated |
| Reason | Outer box of Monitoring Kit was mislabeled with the incorrect part number. |
| Root cause | Error in labeling |
| Action | Integra LifeSciences Corp. sent an Urgent Product Recall Notification letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to quarantine any affected product and arrange for return to Integra by contacting Integra Customer Service Returns at 1-800-654-2873 (choose option 2) to obtain a Return Merchandise Authorization number and place an order for replacement product. Customers were asked to complete the attached "Recall Acknowledgement and Return Form" indicating whether o |
| Quantity | 45 kits |
| Distribution | Nationwide Distribution including CA, CT, GA, HI, IL, KY, MA, NC, NJ, NM. NV, OH, TX, WA, and WI. |
| 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 |