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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 Recall
LifeShield Symbiq Pump Set
see related information
Date Posted March 09, 2010
Recall Status1 Terminated on January 29, 2012
Recall Number Z-1053-2010
Recall Event ID 54080
Premarket Notification
510(K) Number
K041550 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Latex-Free Symbiq Pump Set, convertible pin, 104 inch piggyback with backcheck valve, 2 prepierced injection sites, 0.2 micron filter and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160410428, list number 16041-28.
Code Information Lot numbers: 601375H, 631845H, 641575H, 651615H, and 660975H.
Recalling Firm/
Manufacturer
Hospira Inc.
375 N Field Dr
Lake Forest, Illinois 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
PRODUCTION CONTROLS: 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 21,312 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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = ABBOTT LABORATORIES
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