BEUDAMED
    FDA Recall Terminated

    ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study

    Recall: Z-1028-2011 · Initiated December 21, 2010

    Recall

    Recall Number
    Z-1028-2011
    Event Number
    57504
    Firm
    Salter Laboratories, Division of Regulatory Affairs
    FEI Number
    1314417
    Product Code
    BZQ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 21, 2010
    Posted
    February 3, 2011
    Terminated
    June 6, 2011
    Address
    100 Sycamore Rd, Arvin, CA, 93203-2300

    Description

    ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study

    Reason

    The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.

    Action

    Salter Laboratories, Inc. sent an URGENT PRODUCT RECALL LETTER dated December 20, 2010, to all affected customers. The letter identfied the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for this product and lot number. Contact Salter to arrange for the return of the product. Complete the attached reply form, confirming receipt of the letter, and fax it back to Salter Labs at 1-800-628-4690. For questions regarding this recall call 661-854-3166.

    Distribution

    Nationwide Distribution including CA, CO, DE, ID, IN, KY, MD, MO, and OH,

    Quantity

    41 units