FDA Device

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

Hazard

IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

What You Should Do

Remedy

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.

Products

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; Ma
Brand
Abbott Laboratories HPD/ADD
UPC
Product number 19292-04-01, lots 961815H and 921675H

Units Affected

7,160 units