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

FDA device recall Z-1483-2020 · posted 2020-02-19 · Terminated

Recall details

Recalling firm

Deroyal Industries, Inc. Lafollette

Reason for recall

The sterile packaging has the potential to be compromised.

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.

Root cause

Packaging

Status

Terminated

Product code

DWS

Quantity affected

669 units

Distribution

International distribution of Kuwait City, Kuwait.

Date initiated

2020-02-06

Date posted

2020-02-19

Date terminated

2021-02-11

Location

La Follette, TN