Class 1 Device Recall Hospira brand Symbiq OneChannel Infuser

• Date Initiated by Firm: April 09, 2010
• Date Posted: July 02, 2010
• Recall Status: Terminated on December 03, 2013
• Recall Number: Z-1894-2010
• Recall Event ID: 55854
• 510(K)Number: K041550
• Product Classification: Pump, infusion - Product Code FRN
• Product: Hospira brand Symbiq One-Channel Infuser; List Number: 16026; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica. Intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
• Code Information: All units including List Number Configurations: 16026-04-01/03/04,51/52,53/54, 79/80,81/82,83/84,87/88 and 89/90; 16026-27-89/90; 16026-13-25/26, 53/54.
• Recalling Firm/ Manufacturer: Hospira Inc; 755 Jarvis Dr; Morgan Hill CA 95037-2810
• Manufacturer Reason for Recall: Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.
• FDA Determined Cause: Device Design
• Action: Hospira issued a "Urgent: Medical Device Recall Notification" dated June 11, 2010 to update a previously issued Clinical Bulletin. Customers were informed of the issue and instructed on proper mitigation steps to further avoid the issue associated with the affected product. Consignees were asked to complete and return the Reply Form. For further information, contact Hospira Technical Support Operations at 1-800-332-4002, 6AM to 4PM PST, Monday through Friday.
• Quantity in Commerce: 28,485 total
• Distribution: Worldwide Distribution -- United States (AL, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA and WA), and Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and United Arab Emirates.
• 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