FDA Device

T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

Hazard

The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/mL

What You Should Do

Remedy

Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.

Products

T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laborator
Brand
Abbott Laboratories HPD/ADD
UPC
List number 15252-04-02, lot 940285H

Units Affected

60 units