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 operations.
Recall
- Recall Number
- Z-0759-2012
- Event Number
- 60798
- Firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- FEI Number
- 1000138491
- Product Code
- HBG
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- December 21, 2011
- Posted
- January 13, 2012
- Terminated
- May 10, 2012
- Address
- 3498 West 2400 South, # 1050, Salt Lake City, UT, 84119
Description
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 operations.
Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
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.
(USA) Nationwide Distribution
180 units.