BEUDAMED
    FDA Enforcement Class II Ongoing

    Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.

    Recall: Z-1036-2019 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1036-2019
    Event ID
    82039
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ConvaTec, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2019
    Initiation Date
    January 9, 2019
    Classification Date
    March 21, 2019
    Address
    7900 Triad Center Dr Ste 400, N/A, Greensboro, NC, 27409-9076, United States

    Description

    Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.

    Reason

    An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

    Code Info

    Product Codes/REF Numbers: 417350, 417354; Lot Codes: 7D04313, 7E03449, 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, 487048

    Distribution

    Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.

    Quantity

    1,231,155 units total