BEUDAMED
    FDA Recall Terminated

    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

    Recall: Z-0899-2018 · Initiated October 3, 2017

    Recall

    Recall Number
    Z-0899-2018
    Event Number
    79199
    Firm
    Degania Silicone, Ltd. Degania Bet Dganya Bet Israel
    FEI Number
    7682
    Product Code
    GBX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 3, 2017
    Posted
    February 20, 2018
    Terminated
    October 21, 2020

    Description

    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

    Reason

    Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.

    Action

    An Urgent Medical Device Correction letter, dated October 03, 2017, was sent to the customer. The letter identified the affected device and the reason for the recall. The letter instructed the consignee to check its stock in order to remove all mislabeled product from the market and eliminate potential risk of misuse. The customer was instructed to return the completed Confirmation Sheet to Degania Silicone, as well as any unlabeled product. Questions regarding the recall should be directed to Katia Kayam, Customer Complaints Officer at [email protected].

    Distribution

    US Distribution to Puerto Rico.

    Quantity

    4,000 units