BEUDAMED
    FDA Enforcement Class II Terminated

    Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage

    Recall: Z-2907-2016 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-2907-2016
    Event ID
    75065
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    August 23, 2016
    Classification Date
    September 30, 2016
    Termination Date
    March 29, 2017
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage

    Reason

    During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

    Code Info

    Catalog Number 910420, Lot #0195878 with expiry 10/2018

    Distribution

    Nationwide Distribution to KS only

    Quantity

    18