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FDAJanuary 13, 2020device

Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.6 mm, REF MDP-36K k) 4.0 mm...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

What to do

FDA enforcement status: Terminated

Brands named

teleflex medicalteleflex

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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