BEUDAMED
    FDA Enforcement Class II Terminated

    Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324

    Recall: Z-0090-2019 · Reported October 17, 2018

    Enforcement

    Recall Number
    Z-0090-2019
    Event ID
    80999
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sterilmed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2018
    Initiation Date
    September 17, 2018
    Classification Date
    October 9, 2018
    Termination Date
    August 4, 2020
    Address
    5010 Cheshire Pkwy N Ste 2, Plymouth, MN, 55446-4101, United States

    Description

    Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324

    Reason

    Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.

    Code Info

    All lots with expiration dates prior to 2019-06-08 of the following: (a) Product Code STJ408309, GTIN 10888551044912 (b) Product Code STJ408310, GTIN 10888551044929 (c) Product Code STJ408324, GTIN 10888551044950

    Distribution

    U.S. Nationwide distribution in the states of CA, CO, MN, and WA.

    Quantity

    218 units