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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/
Manufacturer		 Creganna Medical Devices
Parkmore House
Mweeloon
Galway Ireland
For Additional Information Contact Tafzeelur Rahaman
408-856-4459
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
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