FDA Device

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.

Hazard

The sterile packaging has the potential to be compromised.

What You Should Do

Remedy

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.

Products

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.
Brand
Deroyal Industries, Inc. Lafollette
UPC
Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564

Units Affected

669 units