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
FDA Recall Z-0809-2010 · Posted 2010-02-22
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Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2010-01-08
Date Terminated2011-07-20
Product Quantity1,536 sets
Reason for Recall
There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.
Firm 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.
Root Cause
Process control
Distribution Pattern
Minnesota and Utah
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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