BEUDAMED
    FDA Recall Terminated

    Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 0 Injection sites, PVC cassette, non-PVC lined tubing, non-PVC drip chamber. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.

    Recall: Z-0660-06 · Initiated December 8, 2005

    Recall

    Recall Number
    Z-0660-06
    Event Number
    34691
    Firm
    Smiths Medical MD, Inc.
    FEI Number
    2183502
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 8, 2005
    Posted
    March 18, 2006
    Terminated
    January 5, 2007
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 0 Injection sites, PVC cassette, non-PVC lined tubing, non-PVC drip chamber. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.

    Reason

    Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.

    Action

    Affected customers were notified of the recall and asked to return or destroy any unused product.

    Distribution

    South Carolina, Australia, Canada and Puerto Rico.

    Quantity

    7 boxes of 30 Admin. Sets (210 sets in total)