Class 2 Device Recall CADD Administration Sets with Flow Stop

• Date Initiated by Firm: April 22, 2016
• Create Date: May 27, 2016
• Recall Status: Terminated on December 13, 2017
• Recall Number: Z-1831-2016
• Recall Event ID: 73923
• 510(K)Number: K040636
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24. The CADD Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump. The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.
• Code Information: Devices with an expiration date on or before March 2021
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 1265 Grey Fox Rd; Saint Paul MN 55112-6929
• For Additional Information Contact: Smiths Medical Customer Service Departme; 866-831-8399
• Manufacturer Reason for Recall: Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Smiths Medical sent an "Urgent Medical Device Field Correction Action" letter dated April 20, 2016. The letter was addressed to "Clinicians who oversee the use of the CADD Administration Sets with Flow Stop and Distributors thereof". The letter described the Affected devices, Reason for Field Correction Action, Risk to Health, and Instructions to Customers (Distributors and Clinicians). Requested consignees to complete and return the "Field Corrective Action Confirmation Form". For questions regarding this notification, contact Smiths Medical Customer Service Department at 1-866-831-8399.
• Quantity in Commerce: 13,696,830 units
• Distribution: US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE. OUS: UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PORTUGAL, SAUDI ARABIA, SWEDEN, SINGAPORE, TAIWAN, VIET NAAM, SOUTH AFRICA.
• 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