Device recall: ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an…
Class II FDA enforcement event 87231. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Northgate Technologies, Inc. started this device recall on 15 Jan 2021. The firm address in the FDA record is in Elgin, IL. FDA put the recall in Class II. FDA event 87231 has 2 product records. The first FDA enforcement report date is 3 Mar 2021. The record gives the status Terminated, with the termination date 31 Oct 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of FL and OH.
Recalling firm
Northgate Technologies, Inc., Elgin, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1147-2021 | 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 for surgery (laparoscopic surgery). | 25 units | Class II | Terminated | 3 Mar 2021 |
| Z-1148-2021 | 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. | 45 units | Class II | Terminated | 3 Mar 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Apr 2022 | AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe | Device | Class II | 1 |
| 25 Oct 2021 | Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be use | Device | Class II | 1 |
| 10 Mar 2020 | Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/rena | Device | Class II | 3 |
| 24 May 2017 | Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. | Device | Class II | 1 |
| 21 Nov 2016 | Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1147-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 87231. https://recallregister.com/fda/ii/87231/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of FL and OH.
- What quantity of product is in FDA event 87231?
- The event has 2 product records. The first record gives this quantity:
25 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.