BEUDAMED
    FDA Recall Terminated

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    Recall: Z-1898-2012 · Initiated May 30, 2012

    Recall

    Recall Number
    Z-1898-2012
    Event Number
    62272
    Firm
    SALTER LABS
    FEI Number
    1314417
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 30, 2012
    Posted
    June 27, 2012
    Terminated
    July 27, 2012
    Address
    100 Sycamore Rd, Arvin, CA, 93203-2300

    Description

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    Reason

    A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector.

    Action

    The firm, Salter Labs, called their customers to discuss the recall and followed up with a "PRODUCT RECALL" letter dated May 29, 2012. The letter was distributed to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any of the lots in their possession to Salter Labs; contact Salter Labs Customer Service at 1-800-235-4203 to arrange for return of the product, and complete and return the attached form/record via fax to: 661-854-6816 or Toll Free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.

    Distribution

    Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.

    Quantity

    242 cases