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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 Recall
Integra Cranial Access Kit
see related information
Date Posted September 19, 2013
Recall Status1 Terminated on January 28, 2014
Recall Number Z-2260-2013
Recall Event ID 66186
Premarket Notification
510(K) Number
K961113 
Product Classification Clip, Tubal Occlusion - Product Code HGB
Product Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are 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 CSF, and to monitor ICP.
Code Information INSHITH Lots: W1205183,,W1207036,,W1209165,,W1209166,,W1209168,,W1210156,,W1210157,,W1210158,,W1210159,,W1210160,,W1211021,,W1211030,,W1211135,,W1211136,,W1211137,,W1212170 INSHITHND Lots: W1210230 INSHITHRZN Lots: W1209156,,W1211182,,W1212090,,W1212125,,W1212178,,W1301258,,W1302005,,W1302031,,W1303148
Recalling Firm/
Manufacturer
Integra LifeSciences Corp. d.b.a. Integra Pain Management
3498 West 2400 South #1050
Salt Lake City, Utah 84119
For Additional Information Contact David E. Gronostajski
801-886-9505
Manufacturer Reason
for Recall
Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Integra sent an Urgent Voluntary Medical Device Recall letter dated September 4, 2013, to all affected customers that have been shipped unexpired affected product lots of Integra® Cranial Access Kits, Catalogue No.'s INSHITH, INSHITHND, INSHITHRZN.The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review their inventory and immediately stop the use or distribution of any affected product. Customers were instructed to identify and report to Integra if they do or do not have any of the affected product lots. Customers were advised how to return any affected product lot numbers in their possession. Effectiveness Checks will be conducted to determine the level of customers who: - Integra has verified, have been notified, and / or acknowledged the recall either by returning the acknowledgement form. - Indicate they will be returning / have returned unexpired affected product lots of kits. Any affected product lot numbers that are returned from consignees will be forwarded to the Integra Salt Lake City, UT facility for final disposition per its site QMS processes. Customers with questions were advised to contact Customers Service at 1-855-532-1723. For questions regarding this recall call 801-886-9505.
Quantity in Commerce 8,648
Distribution Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HGB and Original Applicant = CLINICAL NEURO SYSTEMS LLC.
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