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U.S. Department of Health and Human Services

Class 3 Device Recall Integra NeuroSciences Combo Kit

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  Class 3 Device Recall Integra NeuroSciences Combo Kit see related information
Date Initiated by Firm February 22, 2011
Date Posted May 13, 2011
Recall Status1 Terminated 3 on May 13, 2011
Recall Number Z-2194-2011
Recall Event ID 58490
510(K)Number K961113  
Product Classification Drills, burrs, trephines & accessories (manual) - Product Code HBG
Product Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119.

A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.
Code Information Lot 171237
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
609-936-6824
Manufacturer Reason
for Recall		 Outer packaging of Combo Kit was mislabeled with an incorrect lot number.
FDA Determined
Cause 2		 Labeling mix-ups
Action Integra LifeSciences Corp. sent a " Urgent Product Recall Notification" letter dated February 22, 2011, to the only affected consignee. It was reported the Combo Kits of SPOO98 / INS- 4500 ( Hermetic Large Style Ventricular Catheter set and drill set for NY) - Catalog # 31046 Lot Number 171237, Outer packages were labeled incorrectly. The customer was advised to return this, and they would be replaced with correctly labeled product. The issue is easily recognizable, and does not pose a safety risk to patients. An acknowledgement form was included to be returned to Integra. Further information is available at 609-936-2485.
Quantity in Commerce 7 Kits
Distribution Nationwide Distribution -- including the state of New York.
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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