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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Peritoneal Introducer Sheaths

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 Class 2 Device Recall Integra Peritoneal Introducer Sheathssee related information
Date Initiated by FirmDecember 22, 2010
Date PostedFebruary 14, 2011
Recall Status1 Terminated 3 on May 07, 2012
Recall NumberZ-1231-2011
Recall Event ID 57550
Product Classification Instrument, shunt system implantation - Product Code GYK
ProductIntegra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124; Manufacturer Integra NeuroSciences Implants S.A., 2905 Route Des Dolines, 06921 SOPHIA ANTIPOLIS Cedex, France; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08536, USA Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. Designed to be used with a Peritoneal Introducer of appropriate length during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus.
Code Information Catalog Number 901124, Lot Number 162956 510 K - K771529
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information ContactJon Caparotta
609-275-0500
Manufacturer Reason
for Recall		Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.
FDA Determined
Cause 2		Labeling mix-ups
ActionIntegra Life Sciences sent an Urgent Product Recall letter dated December 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and quarantine any of the affected product. Contact Integra Customer Service at (800) 654-2873, select option 2 to arrange for product returns. Customers were asked to complete the attached "Recall Acknowledgement and Return Form" indicating the current status of quantities of affected product in their inventory. For questions call (609) 936-2237.
Quantity in Commerce95 units
DistributionNationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.
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.
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