The Recall Desk

FDA (Devices) recall action 71238

Gyrus Acmi, Incorporated recalled 2 products on 2015-06-17

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
2015-06-17
Critical
0
Units
34,270

Why these products were recalled

Potential lack of sterility assurance.

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)··2015-06-17

    Gyrus ACMI Diego Elite Tubeset Recalled for Sterility Assurance Concerns

    Gyrus Acmi is recalling 22,250 boxes of Diego Elite Tubesets due to a potential lack of sterility assurance. The devices are used for ENT and head and neck procedures.

    Product
    Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below;
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-06-17

    Gyrus ACMI Diego Elite Tubeset Recalled for Sterility Assurance Concerns

    Gyrus Acmi is recalling Diego Elite Tubesets due to a potential lack of sterility assurance. The recall affects 12,020 boxes distributed in the US, Canada, and other countries.

    Product
    Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, R
    Category
    Distribution
    0 states