The Recall Desk

FDA (Devices) recall action 84722

TELEFLEX MEDICAL INC recalled 2 products on 2020-02-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-02-26
Critical
0
Units
588,830

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2020-02-26

    Teleflex Medical Recalls Disposable Aortic Punches Due to Packaging Compromise

    Teleflex Medical is recalling 587,066 units of Disposable Aortic Punches because packaging may be compromised, potentially affecting device sterility.

    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.
    Category
    Distribution
    0 states