Class 2 Device Recall Specialty Administration Set Blood Set

• Date Initiated by Firm: December 03, 2004
• Date Posted: February 02, 2005
• Recall Status: Terminated on June 25, 2006
• Recall Number: Z-0470-05
• Recall Event ID: 30603
• 510(K)Number: K811933 K896161 K991599
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: 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
• Code Information: MAR04T08 distributed within the United States.
• Recalling Firm/ Manufacturer: Smiths Medical MD, Inc.; 1265 Grey Fox Rd; Saint Paul MN 55112-6929
• Manufacturer Reason for Recall: 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..
• FDA Determined 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 recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths.
• Quantity in Commerce: 3,600 units (120 cases) within USA. Each contain 30 unit.
• Distribution: worldwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA; 510(K)s with Product Code = FPA; 510(K)s with Product Code = FPA