Z-1054-2010

Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron...

Name: Z-1054-2010 Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron...
Creator: Hospira Inc.
Published: 2009-11-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-11-24 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of 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... on 2009-11-24. The reason FDA records is "Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1054-2010
Status: Terminated
Initiated: 2009-11-24
Posted: 2010-03-09
Terminated: 2012-01-29
Recalling firm: Abbott Medical
Product: 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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 2,016 sets
Distribution: Worldwide Distribution -- United States, Australia, Canada, Costa Rica, India, Mexico, Netherlands, Philippines, Singapore and United Arab Emirates.
Product codes and lots: Lot number: 702195H

Product code FPA

K041550Class IIHospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories / cleared 2004-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)