Z-0808-2010

LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch...

Name: Z-0808-2010 LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch...
Creator: Hospira Inc.
Published: 2010-01-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-01-08 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid... on 2010-01-08. The reason FDA records is "There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure". 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-0808-2010
Status: Terminated
Initiated: 2010-01-08
Posted: 2010-02-22
Terminated: 2011-07-20
Recalling firm: Abbott Medical
Product: LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids using the Symbiq infusion pump; 48 sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 16096-28.
Product code: FPA Set, Administration, Intravascular
Reason for recall: There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 47,904 sets
Distribution: Minnesota and Utah
Product codes and lots: List Number: 16096-28, Lot: 82-028-5H

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)