Recall Z-0472-05 ยท FPA Set, Administration, Intravascular
Smiths Medical MD, Inc.
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 8C
| Date | Feb 2, 2005 (initiated Dec 3, 2004) |
| Status | Terminated |
| Reason | Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate.. |
| Root cause | Other |
| Action | Customers were sent a product Safety & Recall notification via email or regular mail begining 12/03/04 through 12/08/04. A Product Recall form requested the customer for feedback as to Quantity Used, Quantity to be Retained and Quantity to be returned . The Customer Recall Notication states that if no Administration Sets from alternative lots are available and the use of the volumetric pump is essential, follow the instructions in the attached Customer Information Bulletin, which describes how to identify a set which does not have the defect. Customers who find product subject to the recal |
| Quantity | 96,120 units total: 14,400 units (360 cases) Internationally & 81,720 units (2,043 cases) within USA. Each case cont |
| Distribution | worldwide. |
| FDA record | Open on fda.gov |