Class 2 Device Recall Alaris

• Date Initiated by Firm: June 05, 2007
• Date Posted: August 03, 2007
• Recall Status: Terminated on February 10, 2012
• Recall Number: Z-1078-2007
• Recall Event ID: 38215
• 510(K)Number: K872764
• Product Classification: Low sorbing Extension Set (IV Adminstration set) - Product Code FRN
• Product: Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Lot Number 07036013
• Code Information: Lot Number 07036013
• FEI Number: 3003879246
• Recalling Firm/ Manufacturer: Cardinal Health 303 Inc DBA Alaris Products; 10221 Wateridge Cir; San Diego CA 92121-2733
• For Additional Information Contact: Stacy L. Lewis; 858-458-7830
• Manufacturer Reason for Recall: The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.
• FDA Determined Cause: Other
• Action: Recall Notification consists of a phone call and Recall Notification letters to consignees (distributors) as well as direct customers. On June 5, 2007, Cardinal Health began calling customers and distributors to inform them of a recall affecting IV Administration Set, Model C20014, Lot Number 07036013 (Low Sorbing Extension Set). A follow-up Recall Notification Letter was sent on June 11, 2007. The customers and distributors were notified by registered return receipt mail. For direct customers, letters were sent directly to the point of contact at the hospital. For distributors, they were sent multiple copies of the Recall Notification; along with a cover letter outlining their responsibilities to complete the Recall plan and notify their customers as requested.
• Quantity in Commerce: 4,248 sets (59 boxes)
• Distribution: Nationwide.
• 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 = FRN