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Terminated

Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 161010728, REF16101

FDA Recall Z-1062-2010 · Posted 2010-03-09

Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2009-11-24
Date Terminated2012-01-29
Product Quantity9,744 sets

Reason for Recall

Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.

Firm Action

Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041550HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREAbbott Laboratories · 2004-06-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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