Class 2 Device Recall SYMBIQ OneChannel and TwoChannel Infusers

• Date Initiated by Firm: August 28, 2013
• Date Posted: November 20, 2013
• Recall Status: Terminated on November 07, 2016
• Recall Number: Z-0372-2014
• Recall Event ID: 66263
• 510(K)Number: K110901
• Product Classification: Pump, infusion - Product Code FRN
• Product: *** 1) SYMBIQ One-Channel Infuser; ; *** 2) SYMBIQ Two-Channel Infuser;; ; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; ; ; *** E10 batteries can be identified by the "E10" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery.; ; Symbiq is a general-purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intra-arterial, subcutaneous, or irrigation routes of administration.
• Code Information: *** 1) SYMBIQ One-Channel Infuser, List Number: 16026-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/93/94; *** 2) SYMBIQ Two- Channel Infuser, List Number: 16027-04-01/02/03/04/25/26/43/44/45/46/51/52/53/54/55/56/57/58/65/66/69/70/77/78/79/80/81/82/83/84/87/88/89/90/ 93/94; *** X) Battery Pack E10 Part Number: HSP3566-E10; *** X) Battery Pack E09 Part Number: HSP3566-E09
• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Hospira Global Complaint Management; 800-441-4100
• Manufacturer Reason for Recall: Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers.
• FDA Determined Cause: Employee error
• Action: The firm, Hospira, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 28, 2013 to its customers. Hospira contracted with Stericycle, Inc., in Indianapolis, IN for customer notification, response, tracking, returns, effectiveness checks and destruction of returned product starting on August 28, 2013. The letter described the product, problem and actions to be taken. Customers were instructed to: 1) complete and return the attached reply form via fax to 1-866-470-3291 or e-mail to Hospira2921@stericycle.com, even if you do not currently have the affected batteries; 2) contact Stericycle at 1-877-779-7810 (M-F, 8am - 5pm ET) if they require additional response forms; and, 3) return any affected batteries upon receipt of the new (correct) replacement batteries to Stericycle. Customers are also instructed to forward the recall information to any accounts that they may have shipped the affected batteries to and have them contact Stericycle to recieve a reply form and return label. For further inquiries, please contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 6, availabel 24 hours a day/7 days per week.
• Quantity in Commerce: 59 batteries
• Distribution: US Distribution in states of: : KY, MN, ND, NJ, NY, PA, and SD.
• 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 and Original Applicant = HOSPIRA, INC.