Z-0542-2007

LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention...

Name: Z-0542-2007 LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention...
Creator: Hospira Inc.
Published: 2006-12-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-12-20 / Terminated

FDA source

Hospira Inc. began a recall of LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure... on 2006-12-20. The reason FDA records is "The tubing can separate from the set at the filter inlet post". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0542-2007
Status: Terminated
Initiated: 2006-12-20
Posted: 2007-02-27
Terminated: 2008-03-24
Recalling firm: Abbott Medical
Product: LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01
Product code: FPA Set, Administration, Intravascular
Reason for recall: The tubing can separate from the set at the filter inlet post.
FDA root cause: Other
Action: Hospira sent product recall letters dated 12/20/06 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts that the tubing can separate from the set at the filter inlet post due to an inadequate solvent bond. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.
Quantity in commerce: 7,656 sets
Distribution: Nationwide.
Product codes and lots: List 12163-01, lot 39-126-5H

Product code FPA

K830014Class IIHema - Nv Trans. Blood Filter 100/800Abbott Laboratories / cleared 1983-01-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)