Class 2 Device Recall Abbott TUR

• Date Initiated by Firm: May 13, 2003
• Date Posted: June 17, 2003
• Recall Status: Terminated on November 20, 2003
• Recall Number: Z-0934-03
• Recall Event ID: 26348
• Product Classification: Set, Administration, Intravascular - Product Code FPA
• Product: 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
• Code Information: List number 15252-04-02, lot 940285H
• FEI Number: 1415939
• Recalling Firm/ Manufacturer: Abbott Laboratories HPD/ADD; 100/200 Abbott Park Road; Abbott Park IL 60064
• For Additional Information Contact: Abbott Customer Service; 800-222-6883
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 60 units
• Distribution: New Orleans, LA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.