BEUDAMED
    FDA Recall Terminated

    Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

    Recall: Z-0568-2021 · Initiated November 16, 2020

    Recall

    Recall Number
    Z-0568-2021
    Event Number
    86795
    Firm
    Galt Medical Corporation
    FEI Number
    3000718472
    Product Code
    KGZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 16, 2020
    Posted
    December 14, 2020
    Terminated
    November 7, 2022
    Address
    2220 Merritt Dr, Garland, TX, 75041-6137

    Description

    Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

    Reason

    Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.

    Action

    On 11/16/2020, the firm sent an "URGENT-Medical Recall Notice" to customers to inform them that certain Lots of catheters may have a tip geometry with a thicker wall, resulting in a more obtuse tip angle. This obtuse tip angle, if present in the catheter tip, can cause increased insertion resistance through the epidermis layer of the skin. The Recalling Firm is instructing customers to: Note- An updated Customer Notification Letter was sent on 11/20/2020 via email. 1. Identify and segregate the affected lot(s) that are in their possession as well as those in the possession of their end-users. 2. Complete the enclosed Field Correction Reply Forms and email or fax them to the attention of Corrections Coordinator at [email protected] or 214-778-1433. The Recalling Firm has enclosed one form to account for inventory at the customer's facility and an additional form for capturing the same details from their end-users. The form lists the product number, lot number and quantity that the customer has received. The Recalling Firm is pointing out that It is important that even if a customer does not have any product remaining in their possession that they fill out the attached forms (Attachment A & B) noting zero quantity to be returned and email or fax the forms to the Recalling Firm. 3. Ship the returned product to GALT MEDICAL CORP. using Galts carrier account information listed on the forms. 4. Reference Return Authorization Number RMA# GALT_2004 on the outside of the shipping box and include a copy of the Field Correction Reply Forms with your shipment. 5. Once the completed Field Correction Reply Forms have been received and processed, the Recalling Firm will issue a credit to the customer for the product returned. Customer are asked to place a new PO notating Replacement Parts for new products. The cause of the problem has been identified and corrective actions have been implemented to assure this problem does not reoccur. If you h

    Distribution

    U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE

    Quantity

    9,920 catheters (updated on 03/17/2021)