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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield Symbiq Pump Set

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  Class 2 Device Recall LifeShield Symbiq Pump Set see related information
Date Initiated by Firm November 24, 2009
Date Posted March 09, 2010
Recall Status1 Terminated 3 on January 29, 2012
Recall Number Z-1057-2010
Recall Event ID 54080
510(K)Number K041550  
Product Classification Set, administration, intravascular - Product Code FPA
Product Primary Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced sites, 105 inch, Latex-Free, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. made in Costa Rica; product 160890428, list number 16089-28.
Code Information Lot numbers: 732285H, 732295H, 732305H, 732315H, 732425H, 732465H, 741735H, and 741745H.
Recalling Firm/
Manufacturer		 Hospira Inc.
375 N Field Dr
Lake Forest IL 60045-2513
For Additional Information Contact Ms. Ileana Quinones
224-212-4892
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 12,912 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 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 = FPA and Original Applicant = ABBOTT LABORATORIES
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