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U.S. Department of Health and Human Services

Class 2 Device Recall Lumbar Drainage Set

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  Class 2 Device Recall Lumbar Drainage Set see related information
Date Initiated by Firm August 23, 2016
Create Date September 30, 2016
Recall Status1 Terminated 3 on March 29, 2017
Recall Number Z-2910-2016
Recall Event ID 75065
510(K)Number K032817  
Product Classification Shunt, central nervous system and components - Product Code JXG
Product Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1) sealed package of lumbar catheter and External drainage system is finally packaged in a cardboard box. Intended for CSF external drainage
Code Information Catalog Number 910120A, Lot #0195870 with expiry 05/2019
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. 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
Action Integra 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 Commerce 1
Distribution Nationwide Distribution to KS only
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 = INTEGRA NEUROSCIENCES IMPLANTS S.A.
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