31147 Combo Kit W/110-4BT & 30361 including 1 Cranial Kit w/Cam Chuck 1 intracranial pressure & temperature monitoring kit, contains sterile and non-sterile product. Integra NeuroSciences, Integra LifeSciences 3498 West 2400 South, West Valley City, Utah 84119. Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.
FDA Recall Z-0755-2012 · Posted 2012-01-13
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Recall StatusTerminated
Product CodeHBG
Date Initiated2011-12-21
Date Terminated2012-05-10
Product Quantity12 units
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.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
(USA) Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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