TELEFLEX MEDICAL INC recalls 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

Recalled February 26, 2020 · FDA recall Z-1270-2020 · TELEFLEX MEDICAL

Hazard

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

Units

587066 units

Sold at

Worldwide

Description

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

Product

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, REF MDP-40K l) 4.4 mm, REF MDP-44K m) 4.8 mm, REF MDP-48K n) 5.2 mm, REF MDP-52K o) 5.6 mm, REF MDP-56K p) 6.0 mm, REF MDP-60K

Manufacturer(s)

TELEFLEX MEDICAL INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →