Recall Z-0759-2012 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access op
| Date | Jan 13, 2012 (initiated Dec 21, 2011) |
| Status | Terminated |
| Reason | Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine. |
| Root cause | Labeling False and Misleading |
| Action | Integra sent an Urgent: Medical Device Correction Notice letter dated December 21, 2011 to all affected customers. The letter identified the product, problem and actions to be taken. Integra is requesting that customers further distribute the communications along with the package insert to all appropriate health care practitioners at their facility. The letter instructs customers to complete and return the attached acknowledgement form by fax to 609-750-7999. For questions or concerns call 609-750-2814. |
| Quantity | 180 units. |
| Distribution | (USA) Nationwide Distribution |
| 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 |