Recall Z-1483-2020
Deroyal Industries, Inc. Lafollette · initiated February 6, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564
Reason for recall
The sterile packaging has the potential to be compromised.
FDA-determined cause: Packaging
Action taken
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.
Details
- Recall number
- Z-1483-2020
- Initiated
- February 6, 2020
- Posted by FDA
- February 19, 2020
- Terminated
- February 11, 2021
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Quantity
- 669 units
- Distribution
- International distribution of Kuwait City, Kuwait.
- Recalling firm
- Deroyal Industries, Inc. Lafollette, La Follette, TN