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U.S. Department of Health and Human Services

Class 2 Device Recall Gore Tips Set Device

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  Class 2 Device Recall Gore Tips Set Device see related information
Date Initiated by Firm June 22, 2023
Date Posted July 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2249-2023
Recall Event ID 92608
510(K)Number K152913  
Product Classification Introducer, catheter - Product Code DYB
Product Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Code Information UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622
Recalling Firm/
Creganna Medical Devices
Parkmore House
Galway Ireland
For Additional Information Contact Tafzeelur Rahaman
Manufacturer Reason
for Recall
Three lots of product may be labeled with an incorrect expiration day
FDA Determined
Cause 2
Process control
Action Creganna Medical notified its sole consignee on 06/22/2023 via email. The notice explained the problem with the product and informed the consignee of their intention to collaboratively conduct a recall. The sole consignee is notifying their customers by letter delivered by FedEX on 06/28/2023. The product is to be returned to the consignee.
Quantity in Commerce 194 units
Distribution US Nationwide distribution in the state of AZ.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL