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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 Setsee related information
Date Initiated by FirmNovember 24, 2009
Date PostedMarch 09, 2010
Recall Status1 Terminated 3 on January 29, 2012
Recall NumberZ-1063-2010
Recall Event ID 54080
510(K)NumberK041550 
Product Classification Set, administration, intravascular - Product Code FPA
ProductSymbiq Pump Set, detachable, convertible pin piggyback w/backcheck valve, 3 prepierced reseal ports, Option-Lok, Latex-Free, Non-DEHP, 130 in. (330 cm), 15 drops/mL; a sterile Rx single use device; Hospira Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; product 196750428, list number 19675-28
Code Information Lots numbers: 631945H, 641945H, 661415H and 671845H.
Recalling Firm/
Manufacturer		 Hospira Inc.
375 N Field Dr
Lake Forest IL 60045-2513
For Additional Information ContactMs. 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
ActionHospira, 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 Commerce32,688 sets
DistributionWorldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.
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 = FPA
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