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U.S. Department of Health and Human Services

Class 2 Device Recall Micro Ventricular Bolt Pressuring Monitoring, Cranial Access, and Drainage Kit

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  Class 2 Device Recall Micro Ventricular Bolt Pressuring Monitoring, Cranial Access, and Drainage Kit see related information
Date Initiated by Firm February 22, 2011
Date Posted May 10, 2011
Recall Status1 Terminated 3 on May 10, 2011
Recall Number Z-2171-2011
Recall Event ID 58216
510(K)Number K961113  
Product Classification Drills, burrs, trephines & accessories (manual) - Product Code HBG
Product Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119.

Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection.
Code Information Lot number 170314.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
609-936-2311
Manufacturer Reason
for Recall		 Outer box of Monitoring Kit was mislabeled with the incorrect part number.
FDA Determined
Cause 2		 Error in labeling
Action Integra LifeSciences Corp. sent an Urgent Product Recall Notification letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to quarantine any affected product and arrange for return to Integra by contacting Integra Customer Service Returns at 1-800-654-2873 (choose option 2) to obtain a Return Merchandise Authorization number and place an order for replacement product. Customers were asked to complete the attached "Recall Acknowledgement and Return Form" indicating whether or not they possess any of the product identified. For any questions regarding this recall call 609-936-2485.
Quantity in Commerce 45 kits
Distribution Nationwide Distribution including CA, CT, GA, HI, IL, KY, MA, NC, NJ, NM. NV, OH, TX, WA, and WI.
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 = HBG and Original Applicant = CLINICAL NEURO SYSTEMS LLC.
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