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Terminated

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

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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