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U.S. Department of Health and Human Services

Class 2 Device Recall Pilling Aortic Punch

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  Class 2 Device Recall Pilling Aortic Punch see related information
Date Initiated by Firm January 13, 2020
Date Posted January 27, 2020
Recall Status1 Terminated 3 on November 24, 2021
Recall Number Z-1269-2020
Recall Event ID 84722
Product Classification Instruments, Surgical, Cardiovascular - Product Code DWS
Product Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Code Information Lot Number 74B1500674
Recalling Firm/
Manufacturer		 TELEFLEX MEDICAL INC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall		 There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated the recall by letter on 01/13/2020. The actions to be taking be the consignees are as follows: Check inventory. If affected stock is found, discontinue use immediately and quarantine. Complete the acknowledgement form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. For additional questions, contact the local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 1764 units
Distribution Worldwide
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.
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