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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield Primary SYMBIQ Set

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  Class 2 Device Recall LifeShield Primary SYMBIQ Set see related information
Date Initiated by Firm January 08, 2010
Date Posting Updated February 22, 2010
Recall Status1 Terminated 3 on July 20, 2011
Recall Number Z-0808-2010
Recall Event ID 54195
510(K)Number K041550  
Product Classification Set, administration, intravascular - Product Code FPA
Product LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids using the Symbiq infusion pump; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 16096-28.
Code Information List Number: 16096-28, Lot: 82-028-5H
Recalling Firm/
Hospira Inc.
375 N Field Dr
Lake Forest IL 60045-2513
For Additional Information Contact Ms. Ileana Quinones
Manufacturer Reason
for Recall
There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.
FDA Determined
Cause 2
Process control
Action Hospira Medical issued an "Urgent Device Recall" notification dated January 8, 2010 informing consignees of the affected product. The accounts were instructed to examine their inventory and quarantine affected product immediately and arrange for its return. Users were also requested to complete the enclosed reply form and return it to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.
Quantity in Commerce 47,904 sets
Distribution Minnesota and Utah
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