Recall Z-1483-2020 ยท DWS Instruments, Surgical, Cardiovascular
Deroyal Industries, Inc. Lafollette
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.
| Date | Feb 19, 2020 (initiated Feb 6, 2020) |
| Status | Terminated |
| Reason | The sterile packaging has the potential to be compromised. |
| Root cause | 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 re |
| Quantity | 669 units |
| Distribution | International distribution of Kuwait City, Kuwait. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.