The Recall Desk

FDA (Devices) recall action 73254

Volcano Corporation recalled 2 products on 2016-03-09

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
2016-03-09
Critical
0
Units
2,710

Why these products were recalled

Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.

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)··2016-03-09

    Volcano R-100 Sterile Equipment Covers Recalled for Incorrect Expiry Date Labeling

    Volcano Corporation is recalling R-100 Sterile Equipment Covers because the outer shipping boxes may display incorrect expiry dates, although the inner product is correctly labeled.

    Product
    Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-03-09

    Volcano Sterile Equipment Covers Recalled for Incorrect Expiry Date Labeling

    Volcano Corporation is recalling certain lots of R-100 Sterile Equipment Covers because the outer shipping boxes may display incorrect expiry dates, although the inner product is correctly labeled.

    Product
    Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any…
    Category
    Distribution
    0 states