BEUDAMED
    FDA Recall Terminated

    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    Recall: Z-0355-2017 · Initiated November 7, 2014

    Recall

    Recall Number
    Z-0355-2017
    Event Number
    74242
    FEI Number
    1000477110
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 7, 2014
    Terminated
    November 16, 2016
    Address
    Unomedical As Aholmvej 1 3 Osted Roskilde Denmark

    Description

    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    Reason

    Tubing detachment

    Action

    ConvaTec sent an Urgent Medical Device Correction letter to all affected consignees on November 7, 2014. The letter notified the consignees of what action they need to take if they experience a detached tubing. You can continue to use your infusion sets by following the advice below. 1. When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose. 2. As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring. 3. If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure. If you discover the tubing is detached: 1. Do not attempt to reattach the tubing. Replace the infusion set immediately. 2. Treat any high blood sugar based on guidelines provided by your healthcare professional. 3. Call your distributor's Helpline to report the issue. They will give you instructions on how to return the affected infusion set. The letter included a reply card to be returned.

    Distribution

    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

    Quantity

    1,295,515 units