Cranial Access Kit Ref INSHITHNR 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.
This recall has been terminated (originally issued January 13, 2012).
- Recall Initiated
- December 21, 2011
- Posted
- January 13, 2012
- Terminated
- May 10, 2012
- Recall Number
- Z-0750-2012
- Quantity
- 1,160 units.
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Distribution
(USA) Nationwide Distribution
Lot / Code Info
W1003225, W1005159, W1006121, W1008125, W1012057, W1012253, W1101033, W1101106, W1108089, W1108230, W1108226, W1109042.
Root Cause
Labeling False and Misleading
Action Taken
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.