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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira Inc. a Pfizer company

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 Class 2 Device Recall Hospira Inc. a Pfizer companysee related information
Date Initiated by FirmDecember 22, 2015
Create DateFebruary 23, 2016
Recall Status1 Terminated 3 on November 28, 2016
Recall NumberZ-0863-2016
Recall Event ID 73104
510(K)NumberK110901 
Product Classification Pump, infusion - Product Code FRN
ProductThe 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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17334084.
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information ContactKaty 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 2
Nonconforming Material/Component
ActionOn 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 Commerce6634 units.
DistributionU.S. consignees nationwide.*** Foreign consignees in: Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
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