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Terminated

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.

FDA Recall Z-1483-2020 · Posted 2020-02-19

Recalling FirmDeroyal Industries, Inc. Lafollette
Recall StatusTerminated
Product CodeDWS
Date Initiated2020-02-06
Date Terminated2021-02-11
Product Quantity669 units

Reason for Recall

The sterile packaging has the potential to be compromised.

Firm 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].

Root Cause

Packaging

Distribution Pattern

International distribution of Kuwait City, Kuwait.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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