The Recall Desk

FDA (Devices) recall action 65397

Terumo Medical Corporation recalled 2 products on 2013-07-03

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
2013-07-03
Critical
0
Units
570

Why these products were recalled

Medical devices were incorrectly labeled with extended expiration dates.

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)··2013-07-03

    Terumo Pinnacle Destination Peripheral Guiding Sheath Recalled for Labeling Error

    Terumo Medical Corporation is recalling 20 units of Pinnacle Destination Peripheral Guiding Sheaths because they were incorrectly labeled with extended expiration dates.

    Product
    Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-07-03

    Terumo Glidesheath Recalled for Incorrect Expiration Date Labeling

    Terumo Medical Corporation is recalling 550 units of Glidesheath products due to incorrect expiration date labeling.

    Product
    Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
    Category
    Distribution
    0 states