Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, 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 160470701, REF 16047.
FDA Recall Z-1054-2010 · Posted 2010-03-09
Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2009-11-24
Date Terminated2012-01-29
Product Quantity2,016 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.