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.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a component made of untested material, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Northgate Technologies, Inc. is recalling 25 units of the ConMed 50L abdominal insufflator (Catalog Number 72-00258-0 / GS2000). The device is used to maintain an expanded cavity (pneumoperitoneum) to allow the insertion of surgical instruments for visual examination or laparoscopic surgery.
The recall was initiated because an internal tubing component in the flow path was made with incorrect material that was not tested for use with this device. The affected units were distributed nationwide in the states of Florida and Ohio. The lot codes for the recalled units range from 9855JEG to 93879JEG.
Consumers and healthcare facilities should stop using the affected devices and contact Northgate Technologies for further instructions.
The recalled product
- 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…
- Manufacturer
- Northgate Technologies, Inc.
- Hazard
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Codes: 9855JEG to 93879JEG
Distribution
Part of a larger recall action
This product is one of 2 recalled by Northgate Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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