Class 2 Device Recall Zinnanti Injector 2.0

• Date Initiated by Firm: April 24, 2006
• Date Posted: June 01, 2006
• Recall Status: Terminated on December 04, 2007
• Recall Number: Z-1077-06
• Recall Event ID: 35241
• 510(K)Number: K020292
• Product Classification: Cannula, Manipulator/Injector, Uterine - Product Code LKF
• Product: Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin''s test. REF TMI1153.
• Code Information: Lot M20772.
• Recalling Firm/ Manufacturer: Catheter Research, Inc; 6131 W 80th St; Indianapolis IN 46278-1344
• For Additional Information Contact: 317-872-0074 Ext. 141
• Manufacturer Reason for Recall: The uterine stop component was not included with the device.
• FDA Determined Cause: Other
• Action: Distributors were notified by letter dated 4/24/06 and requested to notify their customers to return the product.
• Quantity in Commerce: 660
• Distribution: Minnesota and Spain.
• 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 = LKF