Class 2 Device Recall Bivona

• Date Initiated by Firm: February 20, 2003
• Date Posted: June 12, 2003
• Recall Status: Terminated on December 10, 2003
• Recall Number: Z-0927-03
• Recall Event ID: 25650
• 510(K)Number: K894613 K894614 K922665
• Product Classification: Instrument, Manual, General Obstetric-Gynecologic - Product Code KOH
• Product: Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.
• Code Information: Lot 1134710
• Recalling Firm/ Manufacturer: Portex, Inc; 5700 West 23rd Ave; Gary IN 46406
• For Additional Information Contact: 800-424-8662
• Manufacturer Reason for Recall: May have incorrectly printed graduation markings along the tube shaft.
• FDA Determined Cause: Other
• Action: A recall letter dated February 20, 2003 was issued to each customer. Customers were instructed to cease use of the lot and to return the product to Portex.
• Quantity in Commerce: 49
• Distribution: Nationwide, England and France
• 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.

• 510(K) Database: 510(K)s with Product Code = KOH