Device Recall Burette Administration Set

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.

General Hospital and Personal Use Devices

2

No

worldwide.

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.

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.

General Hospital and Personal Use Devices

2

No

worldwide.

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.

FEB04T32 distributed within the United States.

General Hospital and Personal Use Devices

2

No

worldwide.

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.

FEB04T16, MAR04T20 & APR04T18 distributed within the United States.

General Hospital and Personal Use Devices

2

No

worldwide.

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.

MAR04T12 distributed within the United States.

General Hospital and Personal Use Devices

2

No

worldwide.

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.