Recall Z-2194-2011 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
Integra LifeSciences Corp.
Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.
| Date | May 13, 2011 (initiated Feb 22, 2011) |
| Status | Terminated |
| Reason | Outer packaging of Combo Kit was mislabeled with an incorrect lot number. |
| Root cause | Labeling mix-ups |
| Action | Integra LifeSciences Corp. sent a " Urgent Product Recall Notification" letter dated February 22, 2011, to the only affected consignee. It was reported the Combo Kits of SPOO98 / INS- 4500 ( Hermetic Large Style Ventricular Catheter set and drill set for NY) - Catalog # 31046 Lot Number 171237, Outer packages were labeled incorrectly. The customer was advised to return this, and they would be replaced with correctly labeled product. The issue is easily recognizable, and does not pose a safety risk to patients. An acknowledgement form was included to be returned to Integra. Further info |
| Quantity | 7 Kits |
| Distribution | Nationwide Distribution -- including the state of New York. |
| 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 |