Northgate Technologies Recalls Laparoscopic Insufflators Due to Overpressure Risk
Northgate Technologies is recalling 49 laparoscopic insufflators because they may cause patient overpressure without visual or auditory warnings.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a significant risk of patient injury (overpressure) during surgery without warning, fitting the criteria for a Severe rating.
Plain-English summary
Northgate Technologies, Inc. is recalling 49 laparoscopic insufflators, including the ConMed GS2000, Smith & Nephew 500, Novadaq 50L, and Nebulae I models. These devices are used to provide CO2 gas distention of surgical cavities for diagnostic and operative endoscopy procedures, such as general, pediatric, and bariatric laparoscopic surgeries.
The recall is being issued because the devices could cause a patient overpressure situation without providing any visual or auditory indication or warning. This lack of warning could compromise patient safety during surgical procedures.
The affected devices were distributed worldwide, including in the United States (specifically Florida and Massachusetts) and Canada. Specific serial numbers for the 49 units are listed in the official recall documentation. Healthcare facilities and users should stop using the affected devices and contact Northgate Technologies for further instructions on the recall.
The recalled product
- Product
- Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used fo
- Manufacturer
- Northgate Technologies, Inc.
- Affected units
- 49
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 (20)
- Serial Numbers: #89170HXB
- #89556DYD
- #89652FYA
- #89661FYA
- #89663FYA
- #89664FYA
- #89670FYA
- #89672FYA
- #89675FYA
- #89677FYA
- #89685FYB
- #89697FYB
- #89708GYA
- #89713GYA
- #89719GYB
- #89720GYB
- #89729GYB
- #89732GYB
- #89734GYB
- #89737GYB
Distribution
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