BEUDAMED
    FDA Recall Terminated

    Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.

    Recall: Z-2242-2011 · Initiated April 19, 2011

    Recall

    Recall Number
    Z-2242-2011
    Event Number
    58564
    Firm
    Salter Laboratories, Division of Regulatory Affairs
    FEI Number
    1314417
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 19, 2011
    Posted
    May 23, 2011
    Terminated
    August 23, 2011
    Address
    100 Sycamore Rd, Arvin, CA, 93203-2300

    Description

    Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.

    Reason

    One complaint received of product in box different from what was on label.

    Action

    Salter Laboratories sent a URGENT PRODUCT RECALL NOTIFICATION letter dated April 19, 2011, certified mail to all of the affected consignees, along with a RECALL EFFECTIVENESS CHECK FORM to acknowledge receipt of this communication. It was reported that a package labeled 1600-14, Adult Nasal Cannula actually contained a 25-foot length of tubing and has determined that additional product may have been incorrectly labeled in this manner. No illness or injury would result from this product mix-ups. Should you have any questions, please contact Salter Laboratories at 1-800-235-4203.

    Distribution

    Worldwide Distribution - USA (nationwide) and the country of South America.

    Quantity

    3500 pieces