Device Recall Primary Administration Set

FEB04T29 was 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 8C390 (Reorder No. 21-0325-01) 121 inch length/307 cm, 28ml priming volume, 20 drops/ml, 0 injection sites.

FEB04T08, MAR04T26 & APR04T07 were 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 8C220 (Reorder No. 21-0323-01) 107 inch length/272 cm, 26ml priming volume, 20 drops/ml, 1 standard injection site.

Model # I8C230 (Reorder No. 21-0345-25) distributed outside the United States contains Lot No.: MAR04T03 & APR04T04. Model # 8C230 (Reorder No. 21-0324-01) distributed within the United States contains Lot No.: FEB04T01, FEB04T18, MAR04T02, APR04T03 & APR04T16.

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 Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C230 (Reorder No. (21-0345-25) for product distributed Internationally. Model Number 8C230 (Reorder No. 21-0324-01) for product distributed within the United States.

FEB04T11, FEB04T30, MAR04T05 and MAR04T24 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 CC4203 (Reorder No. 21-0339-01) 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 SureSite Prepierced Injection Sites.

FEB04T09, FEB04T34, MAR04T16 & APR04T05 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 LC4203 (Reorder No. 21-0341-01) 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 needleless Injection sites.