Device Recall Specialty Administration Set

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

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 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.

MAR04T08 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 CC2102 (Reorder No. 21-0309-01) 112 inch length/285 cm, 50ml priming volume, 12 drops/ml (at filter), 1 SureSite Prepierced injection site, 150 micron blood filter, 2 non-vented spikes

FEB04T25 distributed in Japan.

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 I8C4240J (Reorder No. 21-0352-25) Specialty Administration Set described as 107 inch length/272 cm, 27.5ml priming volume, 20 drops/ml and 2 Injection sites and 0.22 micron filter.

FEB04T05, MAR04T30 & APR04T20 distributed Internationally.

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 RC2124 (Reorder No. 21-0441-25) Specialty Administration Set described as 109 inch length/277 cm, 26ml priming volume, 20 drops/ml and 1 Needless Injection site, 15 micron filter.