Devices

Device Recall Burette Administration Set

  • Model / Serial
    FEB04T16, MAR04T20 & APR04T18 distributed within the United States.
  • Product Classification
    General Hospital and Personal Use Devices
  • 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. Model Number CJ4303 (Reorder No. 21-0313-01)110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 SureSite Prepierced injection sites.
  • Manufacturer
    Smiths Medical MD, Inc.
  • 1 Event

Manufacturer

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

6 devices with a similar name

Learn more about the data here

Device Recall Burette Administration Set
  • Model / Serial
    Model # I8C1230J (Reorder No. 21-0301-25) distributed in Japan contains Lot No.: FEB04T28, MAR04T23 & MAR04T34. Model # I8C1230 (Reorder No. 21-0318-25) distributed outside the United States contains Lot No.: FEB04T22, MAR04T31, APR04T06 & APR04T10. Model # 8C1230 (Reorder No. 21-0305-01) distributed within the United States contains Lot No.: FEB04T27 & APR04T13.
  • Product Classification
    General Hospital and Personal Use Devices
  • 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. 3 Model Numbers are used for this same Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 standard injection sites. Model Number I8C1230J (Reorder No. 21-0301-25) for product distributed to Japan. Model Number I8C1230 (Reorder No. (21-0318-25) for product distributed Internationally. Model Number 8C1230 (Reorder No. 21-0305-01) for product distributed within the United States.
  • Manufacturer
    Smiths Medical MD, Inc.
Device Recall Burette Administration Set
  • Model / Serial
    Model # I8C1630 (Reorder No. 21-0319-25) distributed outside the United States contains Lot No.: APR04T02. Model # 8C1630 (Reorder No. 21-0306-01) distributed within the United States contains Lot No.: MAR04T04.
  • Product Classification
    General Hospital and Personal Use Devices
  • 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 Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 60 drops/ml, 3 standard injection sites. Model Number I8C1630 (Reorder No. 21-0319-25) for product distributed Internationally. Model Number 8C1630 (Reorder No. 21-0306-01) for product distributed within the United States.
  • Manufacturer
    Smiths Medical MD, Inc.
Device Recall Burette Administration Set
  • Model / Serial
    FEB04T32 distributed within the United States.
  • Product Classification
    General Hospital and Personal Use Devices
  • 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. Model Number AK2304 (Reorder No. 21-0308-01) 118 inch length/300 cm, 19ml priming volume, 60 drops/ml, 3 standard injection sites and 0.22 micron air-eliminating filter.
  • Manufacturer
    Smiths Medical MD, Inc.
Device Recall Burette Administration Set
  • Model / Serial
    MAR04T12 distributed within the United States.
  • Product Classification
    General Hospital and Personal Use Devices
  • 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. Model Number NJ4303 (Reorder No. 21-0426-01) described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 Luer-Activated Valve injenction Sites Burette set.
  • Manufacturer
    Smiths Medical MD, Inc.
Device Recall Burette Administration Set
  • Model / Serial
    MAR04T15 distributed within the United States.
  • Product Classification
    General Hospital and Personal Use Devices
  • 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. Model Number NK4303 (Reorder No. 21-0427-01) described as 110 inch length/279 cm, 16.5ml priming volume, 60 drops/ml, 3 Luer-Activated Valve injenction Sites Burette set.
  • Manufacturer
    Smiths Medical MD, Inc.
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