The Recall Desk

FDA (Devices) recall action 84991

Covidien Llc recalled 2 products on 2020-03-11

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
2020-03-11
Critical
0
Units
70,361

Why these products were recalled

Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.

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

  • HighFDA (Devices)··2020-03-11

    Recall of Force TriVerse Electrosurgical Kits Due to Sterility Concerns

    Covidien is recalling Force TriVerse Electrosurgical Kits distributed in EMEA due to potential sterile packaging compromise, which may increase infection risk.

    Product
    Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREA
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-03-11

    Recall of Covidien Force TriVerse Electrosurgical Devices Due to Packaging Risk

    The FDA is recalling 70,361 units of Covidien Force TriVerse Electrosurgical Devices because sterile packaging may be compromised, increasing the risk of infection.

    Product
    Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
    Category
    Distribution
    0 states