BEUDAMED
    FDA Recall Terminated

    SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot Code: R0048; Clinitubes Kits: 942-892 (D957P-70-100x1), Lot Codes: R0045 through R0050; Clinitubes Kits: 942-893 (D957P-70-125x1), Lot Codes: R0058 through R0063; Clinitubes Kits: 942-898 (D957P-70-70x1), Lot Code: R0019. Each of the kits listed above contains one (1) bag of Capillary Caps, 905-787.

    Recall: Z-1442-06 · Initiated June 29, 2006

    Recall

    Recall Number
    Z-1442-06
    Event Number
    36007
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    GIO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2006
    Posted
    August 26, 2006
    Terminated
    February 24, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot Code: R0048; Clinitubes Kits: 942-892 (D957P-70-100x1), Lot Codes: R0045 through R0050; Clinitubes Kits: 942-893 (D957P-70-125x1), Lot Codes: R0058 through R0063; Clinitubes Kits: 942-898 (D957P-70-70x1), Lot Code: R0019. Each of the kits listed above contains one (1) bag of Capillary Caps, 905-787.

    Reason

    Leaking Capillary Caps- The dimensions and shapes of the capillary caps do not fit the capillary tubes correctly. This can cause the capillary tubes to leak.

    Action

    The firm sent a recall letter to their customers on 6/29/2006. The letter identifies the problem and kit numbers and lot numbers for the affected kits, and as well as the Lot Numbers for the defective 905-787, capillary caps subject to recall. The letter requests that the customers: 1) Examine their inventories for the presence of the affected lot numbered products; 2) Identify and discard any of the recalled bags contained in the kits or ordered separately; and 3) Return the attached FAX FORM indicating the amount of replacement product required and the address to which the replacement product should be mailed. The letter also provides a telephone number to reach the firm''s Technical Support Department should the customer have any questions concerning the recall letter.

    Distribution

    Nationwide distribution --- including states of IL, NJ, NE, MO, PA, NY, WI, MN, UT, WA, OK, FL, MI, TX, CA, IN, OH, MO, OR, AK, MA, MS, VA, NH, NM, AR, TN, WI, ID, CT, SD, ME, NC, GA, NC , LA, CO, UT, NC, MD, AL, ND, FL, IA, AZ, SC, KY, KS, and NV.

    Quantity

    886 units