Device Recall Primary Checkvalve for Secondary (piggyback) Administration Set

Model # I8C4220 (Reorder No. 21-0349-25) distributed outside the United States contains Lot No. FEB04T24 & MAR04T14. Model # 8C4220 (Reorder No. 21-0328-01) distributed within the United States contains Lot No.: MAR04T21 & APR04T08.

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 Checkvalve Set for secondary (piggyback) Administration described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C4220 (Reorder No. 21-0349-25) for product distributed Internationally. Model Number 8C4220 (Reorder No. 21-0328-01) for product distributed within the United States.

FEB04T31, MAR04T22 & APR04T19 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 CC1301 (Reorder No. 21-0334-01) Primary Checkvalve for Secondary (piggyback) Administration Set described as 115 inch length/292 cm, 27ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites.