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U.S. Department of Health and Human Services

Class 2 Device Recall Teleflex

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  Class 2 Device Recall Teleflex see related information
Date Initiated by Firm February 06, 2020
Date Posted February 19, 2020
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-1483-2020
Recall Event ID 84943
Product Classification Instruments, surgical, cardiovascular - Product Code DWS
Product Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
Code Information Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564
Recalling Firm/
Manufacturer		 Deroyal Industries, Inc. Lafollette
1501 E Central Ave
La Follette TN 37766-2892
For Additional Information Contact Theresa Marsee
865-938-7828
Manufacturer Reason
for Recall		 The sterile packaging has the potential to be compromised.
FDA Determined
Cause 2		 Packaging
Action DeRoyal notified customers on about 02/06/2020 via "URGENT! RECALL NOTICE" letter. Customers were informed that the Teleflex Pilling Aortic Punch is an item that is not placed inside the sterile tray, is a sterile item that is placed on the outside of the sterilized kit/tray. Instructions included to identify and quarantine any affected products on hand and complete and return the Notice of Return Form-Credit Only via fax to 865-362-3716 or email to recalls@deroyal.com. Questions or concerns can be directed to Camden Kitchen at ckitchen@deroyal.com or by phone 865-362-6171, or email at recalls@deroyal.com.
Quantity in Commerce 669 units
Distribution International distribution of Kuwait City, Kuwait.
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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