Z-1483-2020Class II

Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery...

Name: Z-1483-2020 Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery...
Creator: Deroyal Industries, Inc. Lafollette
Published: 2020-02-06
License: https://open.fda.gov/license/

Deroyal Industries, Inc. Lafollette / initiated 2020-02-06 / Terminated / root cause: packaging

FDA source

Deroyal Industries, Inc. Lafollette began a recall of 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... on 2020-02-06. FDA classified it as Class II and gives the reason as "The sterile packaging has the potential to be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1483-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-06
Posted: 2020-02-19
Terminated: 2021-02-11
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.
Product code: DWS Instruments, Surgical, Cardiovascular
Reason for recall: The sterile packaging has the potential to be compromised.
Root cause tag: packaging
FDA 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 [email protected]. Questions or concerns can be directed to Camden Kitchen at [email protected] or by phone 865-362-6171, or email at [email protected].
Quantity in commerce: 669 units
Distribution: International distribution of Kuwait City, Kuwait.
Product codes and lots: Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1483-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1483-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13

Product code DWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)