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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Suction Reservoir with AntiReflux Valve

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  Class 2 Device Recall Integra Suction Reservoir with AntiReflux Valve see related information
Date Initiated by Firm May 07, 2010
Date Posted September 28, 2010
Recall Status1 Terminated 3 on August 27, 2012
Recall Number Z-2588-2010
Recall Event ID 55708
Product Classification Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
Product Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter;
Sterile, Rx only.
Manufactured by Integra NeuroSciences Implants S.A.,
Sophia Antipolis Cedex, France;
distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538;
This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits under catalog number 31223 and 31253.
Code Information Catalog number: 910-500: lot codes 156618, 155186, 155817, 1561194, 156484, 157140, 157345, 157995, 158188, 158690, 158849, 159155. Catalog number: 31223; lot numbers 158817, 156484. 157140, 157345, 156618; Catalog number: 31253: lot numbers: 158817, 156484, 157345, 158690, 156618.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact David Gronostajski
609-936-6822
Manufacturer Reason
for Recall		 The sterility of the product may be compromised. Integra LifeSciences Corp. received a recall notification from Saint-Gobain Performance Plastics, France, contract manufacturer of the Integra Suction Reservoir with Anti-Reflux Valve, that the product's sterility may be affected by a sterilization issue discovered by the supplier.
FDA Determined
Cause 2		 Other
Action Integra sent Urgent Product Recall letters dated May 7, 2010 to customers identifying the affected product, the sterility issue, and actions to be taken by the customer. Customers are instructed to quarantine and return all affected inventory to Integra's distribution center in Sparks, NV, using a Returned Material Authorization Number received from Integra LIfeSciences Customer Service at 800 654-2873. All Customers are requested to return the attached "Recall Acknowledgement. and Return Form" Integra LIfeSciences can be contacted at 609-936-2495.
Quantity in Commerce 313 units
Distribution Worldwide Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WI, and the countries of Australia, Chile, Costa Rica, and Sri Lanka.
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.
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