Class 2 Device Recall Hospira Inc. a Pfizer company

• Date Initiated by Firm: December 22, 2015
• Create Date: February 23, 2016
• Recall Status: Terminated on November 28, 2016
• Recall Number: Z-0863-2016
• Recall Event ID: 73104
• 510(K)Number: K110901
• Product Classification: Pump, infusion - Product Code FRN
• Product: The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion, Centers, Hospice, Sub acute facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.
• Code Information: Lot Code 16026 &16027 with the following serial numbers: 14339221, 14339224, 14339232, 14339261, 14339275, 14339296, 14339308, 14339321, 14339335, 14339349, 14339353, 14339357, 14339371, 14339372, 14339378, 14339387, 14339391, 14339396, 14339401, 14339504, 14339515, 14339553, 14339710, 14339719, 14339725, 14339733, 14339738, 14339742, 14339748, 14339761, 14339769, 14339771, 14339799, 14339815, 14339822, 14339851, 14339887, 14339888, 14339904, 14339913, 14339964, 14339989, 14339998, 14339999, 14340001, 14340014, 14340041, 14340042, 14340069, 14340070, 14340071, 14340094, 14340096, 14340110, 14340117, 14340119, 14340120, 14340122, 14340123, 14340124, 14340127, 14340133, 14340134, 14340138, 14340143, 14340144, 14340146, 14340147, 14340153, 14340154, 14340158, 14340163, 14340176, 14340182, 14340184, 14340186, 14340188, 14340200, 14340209, 14340211, 14340214, 14340225, 14340227, 14340232, 14340245, 14340248, 14340251, 14340253, 14340255, 14340263, 14340264, 14340268, 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• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Katy Narlock; 224-212-3116
• Manufacturer Reason for Recall: Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On December 22, 2015 Stericycle, Inc. sent an URGENT MEDICAL DEVICE CORRECTION notification to direct consignees of record via traceable mailing. The notification included a description of the recall, risk to health information and necessary actions to be performed by the direct account. These include: an inspection of the affected devices for missing rubber stop pad on the Symbiq pole clamp assemblies at the direct accounts.If missing rubber stop pads were discovered they were advised to contact Hospira's Advanced Knowledge Center at 1-800-241-4002, option 4, to receive a replacement pole clamp assembly or be directed to a field Service Engineer who will replace the pole clamp. Hospira ALso advised informing healthcare professionals at their institution about the issue and complete the attached reply form and return it by e-mail or fax at: 1-800-441-4100/1-800-241-4002 or at ProductComplaintsPP@hospira.com Finally customers where advised to notify FDA of any adverse events through FDA's MedWatch Adverse Event Reporting program.
• Quantity in Commerce: 6634 units.
• Distribution: U.S. consignees nationwide.*** Foreign consignees in: Canada.
• 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.