BEUDAMED
    FDA Recall Terminated

    Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411

    Recall: Z-0835-2020 · Initiated December 2, 2019

    Recall

    Recall Number
    Z-0835-2020
    Event Number
    84274
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 2, 2019
    Terminated
    July 6, 2020
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    Description

    Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411

    Reason

    One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

    Action

    Urgent Medical Device Correction notification letters dated 11/15/19 were sent to customers. Actions to be taken by the Customer/Distributor/User: 1. Immediately check your inventories and apply the sticker/labels as directed. If you are an end user: Please adhere one label to the outside of the battery door compartment of your analyzer and apply the other label to the analyzer user guide. If you are a distributor: Please remove the tape liner on the back of the large sticker leaving both small labels intact for the end user to apply. Apply the large sticker to the top panel of the analyzer box, and press firmly. 2. If you have further distributed this product, immediately identify the users and notify them at once of this product correction. Forward this notice, stickers, and response form to all customers/users who did, or who may have, received, this product. 3. Once you have taken the appropriate action, please fill out the attached response form and return it to PTS Diagnostics via the information below. It is important that you complete and return the response form, even if you do not have affected product on hand. 4. Please contact PTS for additional stickers and a PDF version of this letter and response form, if needed. Thank you for your prompt action, and we apologize for any inconvenience this issue may have caused you and your facility. If you have any questions, please contact Customer Service, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 319-870-5610 or 877-870-5610 (U.S. toll-free), or via email at [email protected].

    Distribution

    The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad, UAE.

    Quantity

    44,448 total