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U.S. Department of Health and Human Services

Class 2 Device Recall Symbiq Pump Set

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 Class 2 Device Recall Symbiq Pump Set see related information
Date Posted March 09, 2010
Recall Status1 Terminated on January 29, 2012
Recall Number Z-1054-2010
Recall Event ID 54080
510(K)Number K041550 
Product Classification Set, administration, intravascular - Product Code FPA
Product Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 160470701, REF 16047.
Code Information Lot number: 702195H
Recalling Firm/
Hospira Inc.
375 N Field Dr
Lake Forest IL 60045-2513
For Additional Information Contact Ms. Ileana Quinones
Manufacturer Reason
for Recall
Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
FDA Determined
Cause 2
Process control
Action Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.
Quantity in Commerce 2,016 sets
Distribution Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.