Class 2 Device Recall Low Volume Extension Set, 72

• Date Initiated by Firm: May 04, 2015
• Date Posted: June 08, 2015
• Recall Status: Terminated on January 20, 2016
• Recall Number: Z-1730-2015
• Recall Event ID: 71142
• 510(K)Number: K831087
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
• Code Information: Product Reorder Number: 537235C; Lot #2761409
• FEI Number: 1526863
• Recalling Firm/ Manufacturer: Smiths Medical Asd Inc; 6250 Shier Rings Rd; Dublin OH 43016-1270
• For Additional Information Contact: Mr. D. David Clute; 614-889-2220
• Manufacturer Reason for Recall: Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.
• FDA Determined Cause: Process control
• Action: Smiths Medical sent Urgent Medical Device Recall Notice letters, dated 4 May 2015, requiring its customers to return all affected unused Extension Sets. Please take the following actions: 1. Customers are to inspect their inventory and quarantine any affected Extension Sets. 2. Complete and return the attached Confirmation Form by Fax or by e-mail 3. Upon receipt of the completed form, a customer service representative will contact customers to arrange for exchange of their unused affected Extension Sets for credit or replacement. The notice shall be passed on to all personnel who need to be aware, including points of use. If these affected Extension Sets have been further distributed to other persons or facilities, please promptly forward the recipients a copy of this Urgent Medical Device Recall Notice.
• Quantity in Commerce: 6,000 units
• Distribution: Distributed to the states of KY, MN, NJ, UT, & WI.
• 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