BEUDAMED
    FDA Recall Terminated

    Integra 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.

    Recall: Z-1231-2011 · Initiated December 22, 2010

    Recall

    Recall Number
    Z-1231-2011
    Event Number
    57550
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    GYK
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    December 22, 2010
    Posted
    February 14, 2011
    Terminated
    May 7, 2012
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra 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.

    Reason

    Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.

    Action

    Integra 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.

    Distribution

    Nationwide Distribution including CO, FL, GA, MO, NC, NJ, PA, TX, UT, and WI.

    Quantity

    95 units