BEUDAMED
    FDA Recall Terminated

    remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Lenexa, KS. Product is a sterile system recommended for use in qualitative procedures for the collection of clinical specimens and transport to the laboratory for microbiological culture of anaerobic, facultative, and aerobic organisms.

    Recall: Z-1139-2010 · Initiated January 18, 2010

    Recall

    Recall Number
    Z-1139-2010
    Event Number
    54281
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    JSM
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 18, 2010
    Posted
    March 15, 2010
    Terminated
    April 25, 2012
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. The firm name on the label is remel, Lenexa, KS. Product is a sterile system recommended for use in qualitative procedures for the collection of clinical specimens and transport to the laboratory for microbiological culture of anaerobic, facultative, and aerobic organisms.

    Reason

    Pouch may be inadequately heat sealed compromising sterility

    Action

    An IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" dated January 18, 2010, was sent to customers via regular mail. The notice described the product, problem, and action to be taken by the customers. The customers are requested to: review their inventory for the indicated product, discard all remaining units of the product lot, complete the "Product Inventory Checklist" enclosed to report the amount of product they wanted replaced or credited, and return by February 1, 2010 regardless if they have affected product and/or have verbally contacted the firm. If you have any inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 (USA) or 913-888-0930 (International).

    Distribution

    Nationwide distribution: MI, MA, WV, CO, ME, FL, NJ, MD, WA, AZ, VA, CA, KS, IL, MO, AL, TN

    Quantity

    154/10-unit packages