BEUDAMED
    FDA Recall Terminated

    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

    Recall: Z-1732-2019 · Initiated February 11, 2019

    Recall

    Recall Number
    Z-1732-2019
    Event Number
    82387
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    BTO
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 11, 2019
    Terminated
    November 2, 2020
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

    Reason

    Packaged with an incorrect size inner cannula.

    Action

    During the week of February 11, 2019, the firm sent URGENT MEDICAL DEVICE FIELD SAFETY NOTICE emails to their consignees advising them to check their stock, complete an enclosed. INSTRUCTIONS TO CUSTOMERS: 1.Locate and determine the number of affected products in your possession. (Product Number: 100/856/080 Lot Number: 3578884) 2.Complete the attached Response Form within 10 days and return it to [email protected], even if you do not have any of the affected product in your possession. 3.Return affected product to Stericycle utilizing the pre-paid shipping labels included with this notice. Include a copy of your completed Response Form inside EACH BOX of returned product to facilitate processing of credit. Ensure boxes are sealed and labeled with your facility name prior to shipping. 4.DISTRIBUTORS: If you have distributed potentially affected devices to your customers, please immediately notify them of this Field Safety Corrective Action. Smiths Medical is committed to providing quality products and service to its customers. We apologize for any inconvenience this situation may cause. If you have any questions regarding this notification, please contact Smiths Medical via email at [email protected]. FIELD SAFETY NOTICE RESPONSE FORM and return an affected devices to Stericycle. The emails also instructed distributors to conduct a subrecall.

    Distribution

    Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland

    Quantity

    7,840