Device Recall Specialty Administration Set low adsorption

  • Model / Serial
    Model # I8C290 (Reorder No. 21-0317-25) distributed outside of the United States contains Lot no.: FEB04T17 & APR04T09. Model # 8C290 (Reorder No. 21-0304-01) distributed within the United States contains Lot no.: FEB04T06, MAR04T07, APR04T23
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    worldwide.
  • Product Description
    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Specialty Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 0 injection sites, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Model Number I8C290 (Reorder No. 21-0317-25) for product distributed Internationally. Model Number 8C290 (Reorder No. 21-0304-01) for product distributed within the United States.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA