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U.S. Department of Health and Human Services

Class 2 Device Recall Zinnanti Injector 2.0

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  Class 2 Device Recall Zinnanti Injector 2.0 see related information
Date Initiated by Firm April 24, 2006
Date Posted June 01, 2006
Recall Status1 Terminated 3 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 2
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 and Original Applicant = CATHETER RESEARCH, INC.
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