BEUDAMED
    FDA Enforcement Class II Ongoing

    Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,

    Recall: Z-0838-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0838-2020
    Event ID
    84460
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Imactis
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2020
    Initiation Date
    August 1, 2019
    Classification Date
    January 22, 2020
    Address
    20 Rue Du Tour De L Eau, St Martin D Heres, N/A, France

    Description

    Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,

    Reason

    The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.

    Code Info

    Lot # 18120001/Exp. 2020-04-01 and Lot # 19040001/Exp. 2021-01-22

    Distribution

    US: WI & IL

    Quantity

    122 kits