BEUDAMED
    FDA Recall Terminated

    SurFlo IV Catheter

    Recall: Z-1896-2017 · Initiated August 5, 2015

    Recall

    Recall Number
    Z-1896-2017
    Event Number
    76948
    Firm
    Terumo Medical Corporation
    FEI Number
    1118880
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 5, 2015
    Terminated
    May 1, 2017
    Address
    950 Elkton Blvd, Elkton, MD, 21921-5322

    Description

    SurFlo IV Catheter

    Reason

    According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal.

    Action

    Terumo sent an Urgent Product Bulletin letter dated August 3, 2015. The letter identified the product the problem and the action needed to be taken by the customer. 1. CUSTOMERS MUST IMMEDIATELY DISCONTINUE USE, AND QUARANTINE ANY AVAILABLE STOCK, OF THE LISTED PRODUCT CODES. 2. DISTRIBUTORS MUST NOT DISTRIBUTE ANY OF THE LISTED PRODUCT CODES, QUARANTINE ANY AVAILABLE STOCK AND SEND THIS RECALL BULLETIN IMMEDIATELY TO EACH CUSTOMER THAT RECEIVED THESE PRODUCTS TO INFORM THEM OF THIS ISSUE. Terumo is taking this action to assure the safety of our customers and their patients even though it may cause a significant inconvenience. If this creates a critical shortage, please contact us immediately so we may try to provide assistance in procuring replacement or alternative product. For further questions, please call (410) 392-7226

    Distribution

    US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.

    Quantity

    2,478,200