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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield Primary I.V. Set

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 Class 2 Recall
LifeShield Primary I.V. Set
see related information
Date Posted February 22, 2010
Recall Status1 Terminated on July 20, 2011
Recall Number Z-0809-2010
Recall Event ID 54195
Premarket Notification
510(K) Number
K052722 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp, backcheck valve, 4 Clave ports, piggyback with Option-Loc, attached extension set, 122 inch, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 19689-01
Code Information List Number: 19689-01, Lot Number: 81-147-5H.
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
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
PRODUCTION CONTROLS: 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 1,536 sets
Distribution Minnesota and Utah
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 = HOSPIRA, INC.
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