FDA Recall Terminated

Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C4209 (Reorder No. 21-0327-01) Primary one-way Checkvalve below pump Administration Set described as 115 inch length/292 cm, 27.5ml priming volume, 20 drops/ml and 3 Injection sites.

Recall: Z-0486-05 · Initiated December 3, 2004

Recall

Recall Number: Z-0486-05
Event Number: 30603
Firm: Smiths Medical MD, Inc.
FEI Number: 2183502
Product Code: FPA
Status: Terminated
Root Cause: Other
Initiated: December 3, 2004
Posted: February 2, 2005
Terminated: June 25, 2006
Address: 1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

Description

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..

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 recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths.

Distribution

worldwide.

Quantity

4,800 units (120 cases) within USA. Each case contains 40 units.