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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 Device Recall LifeShield Primary I.V. Setsee related information
Date Initiated by FirmJanuary 08, 2010
Date PostedFebruary 22, 2010
Recall Status1 Terminated 3 on July 20, 2011
Recall NumberZ-0809-2010
Recall Event ID 54195
510(K)NumberK052722 
Product Classification Set, administration, intravascular - Product Code FPA
ProductLifeShield 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 IL 60045-2513
For Additional Information ContactMs. 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		Process control
ActionHospira 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 Commerce1,536 sets
DistributionMinnesota and Utah
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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