Recall Z-0489-05 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. 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.
| 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 | 1,040 units (26 cases) Japan. Each case contains 40 units. |
| Distribution | worldwide. |
| FDA record | Open on fda.gov |