Z-0914-03

LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck...

Name: Z-0914-03 LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck...
Creator: Abbott Laboratories HPD/ADD
Published: 2003-05-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-05-13 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories HPD/ADD began a recall of LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow... on 2003-05-13. The reason FDA records is "IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0914-03
Status: Terminated
Initiated: 2003-05-13
Posted: 2003-06-05
Terminated: 2003-11-20
Recalling firm: Abbott Medical
Product: LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
Product code: FPA Set, Administration, Intravascular
Reason for recall: IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recall letter dated 5/12/03 sent to the accounts on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lots to Abbott for credit.
Quantity in commerce: 7,160 units
Distribution: Nationwide. California, Colorado, Connecticut, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin.
Product codes and lots: Product number 19292-04-01, lots 961815H and 921675H

Product code FPA

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)