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U.S. Department of Health and Human Services

Class 2 Device Recall Drainage Accessory Kit

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 Class 2 Device Recall Drainage Accessory Kitsee related information
Date Initiated by FirmAugust 23, 2016
Create DateSeptember 30, 2016
Recall Status1 Terminated 3 on March 29, 2017
Recall NumberZ-2908-2016
Recall Event ID 75065
510(K)NumberK855058 
Product Classification Shunt, central nervous system and components - Product Code JXG
ProductIntegra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
Code Information Catalog Number 910122, Lot #0195615 with expiry 04/2019
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information ContactDr. Patricia Kihn
717-840-3431
Manufacturer Reason
for Recall		During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
FDA Determined
Cause 2		Process control
ActionIntegra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
Quantity in Commerce1
DistributionNationwide Distribution to KS only
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JXG
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