BEUDAMED
    FDA Recall Terminated

    AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.

    Recall: Z-0135-2012 · Initiated October 12, 2011

    Recall

    Recall Number
    Z-0135-2012
    Event Number
    60175
    Firm
    Sierra Scientific Instruments Inc
    FEI Number
    3005344223
    Product Code
    FFX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 12, 2011
    Posted
    October 28, 2011
    Terminated
    August 30, 2012
    Address
    5757 W Century Blvd, Ste 660, Los Angeles, CA, 90045-6456

    Description

    AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.

    Reason

    The recall was initiated after Given Imaging received a test report during a Canadian licensing process where the AR ManoShield exhibited pinholes and did not pass the test, the Field Safety Corrective Action (FSCA) Committee was convened. As a result of the data discussed during this meeting, a decision was made to voluntarily recall this product, and cease its further commercialization or distr

    Action

    Given Imaging sent an "Urgent Product Recall 1st Notice" letter with an attached Device Recall Confirmation Form (via Fed Ex with signature for tracking purposes) to all customers who purchased the AR ManoShield, part numbers MSS-3599. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were instructed to locate the affected product and removed from use immediately. The letter stated that if the affected product have been further distributed, forward this letter immediately to all customers who received the affected product. Customers were asked to complete and return the enclosed confirmation form as per the instructions. Customers with any questions were instructed to contact Karla Guerrero at (310) 641-8492 ext. 2138 or email at [email protected].

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Chile, China, Columbia, Ecuador, France, Germany, Israel, Mexico, Poland, Portugal, Sweden, and Switzerland.

    Quantity

    292 units