FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1483-2020
- Recalling firm
- Deroyal Industries, Inc. Lafollette
- 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.
- Status
- Terminated
- Initiated
- 2020-02-06
- Posted
- 2020-02-19
- Terminated
- 2021-02-11
- 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 recalls@deroyal.com.
- Quantity
- 669 units
- Distribution
- International distribution of Kuwait City, Kuwait.
- Lot, serial or model codes
- Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWS
- Firm FEI
- 3005011024
- Firm city
- La Follette
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28