Deroyal Industries, Inc. Lafollette recalls Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Prod…

Recall date

February 6, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1483-2020

FDA classification

Class II

Brand / firm

Deroyal Industries, Inc. Lafollette

Sold / distributed

International distribution of Kuwait City, Kuwait.

Why it was recalled

The sterile packaging has the potential to be compromised.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.