Reported Mar 25, 2020 · Terminated

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

Deroyal Industries, Inc. Lafollette

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Deroyal Industries, Inc. Lafollette · 1501 E Central Ave · La Follette, TN · 37766-2892

Is this the product you have?

  • Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac
  • Surgery Kit - Product UsageThis device is used for cardiovascular surgical procedures
Lot codes and dates
  • Catalog Number DP40K
  • Lot Numbers
    • 74F1802710
    • 74G1802678
    • 74H1800763
    • 74D1900657
    • 74C1900811
    • 74D1700564
Amount recalled
669 units

Why it was recalled

The sterile packaging has the potential to be compromised.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 11, 2021 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.