The Recall Desk

FDA (Devices) recall action 87231

Northgate Technologies, Inc. recalled 2 products on 2021-03-03

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
2021-03-03
Critical
0
Units
70

Why these products were recalled

An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-03-03

    Northgate Recalls ConMed Abdominal Insufflators Due to Incorrect Tubing Material

    Northgate Technologies is recalling 25 ConMed 50L abdominal insufflators because an internal tubing component was made with untested material.

    Product
    ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or fo
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2021-03-03

    Northgate Recalls Steris CO2MPACT Endoscopic Insufflator Systems Due to Tubing Material Error

    Northgate Technologies is recalling 45 Steris CO2MPACT Endoscopic Insufflator systems because an internal tubing component was made with incorrect, untested material.

    Product
    Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
    Category
    Distribution
    2 states