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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Cranial Access Kit

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  Class 2 Device Recall Integra Cranial Access Kit see related information
Date Initiated by Firm November 26, 2013
Date Posted December 20, 2013
Recall Status1 Terminated 3 on April 09, 2014
Recall Number Z-0551-2014
Recall Event ID 66949
510(K)Number K042359  
Product Classification Shunt, Central Nervous System And Components - Product Code JXG
Product Integra Cranial Access Kit, Model Number HITHSP10, Rx Only.
Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.
Code Information Lot No. W1302120 Expires 2/1/2014  Lot No. W1305038 Expires 8/1/2015  Lot No. W1306137 Expires 9/1/2014 
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. d.b.a. Integra Pain Management
3498 West 2400 South #1050
Salt Lake City UT 84119
For Additional Information Contact Mr. David E. Gronostajski
609-936-6822
Manufacturer Reason
for Recall		 Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.
FDA Determined
Cause 2		 Labeling mix-ups
Action Integra sent an Urgent Voluntary Medical Device Recall letter dated November 26, 2013, to all affected consignees. The letter identified the product, the problem, the action to be taken by the consignee and included a Recall Acknowledgement and Return form. Consignees were instructed to review their inventory and determine if they have any affected product, stop using the affected product immediately and remove from service. Consignees were instructed to complete the attached form even if they do not have the affected product in their inventory and return by email or fax as indicated on the form. When the form is received Customer Service will send an RMA number and directions to return the product. Customers with questions were instructed to contact Customer Service at 1-855-532-1723 or their Integra sales representative at 909-201-4099. For questions regarding this recall call 609-936-6822.
Quantity in Commerce 731
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JXG and Original Applicant = MEDICAL DESIGNS, LLC
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