FDA-Device2020-03-25Class II

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.

Deroyal Industries, Inc. Lafollette
Hazard

The sterile packaging has the potential to be compromised.

Sold states
International distribution of Kuwait City, Kuwait.
Affected count
669 units
Manufactured in
1501 E Central Ave, La Follette, TN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2020

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