Nitrous Oxide Cartridges Recalled Due to Premature Valve Opening
Integra Miltex CryoSolutions N2O cartridges are recalled because the valve may open prematurely, causing partial or complete cartridge emptying before use. Affected units were distributed nationwide and to Canada.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a functional defect (premature valve opening) with no documented harm mechanism or actual injuries reported, warranting a Moderate severity score.
Plain-English summary
Integra Miltex CryoSolutions Cartridges (Model C-CA-23) containing 23.5g of nitrous oxide are being recalled due to a manufacturing defect. During assembly, the valve connecting the cartridge to its body part may open prematurely, resulting in partial or complete emptying of the cartridge before its intended use.
Approximately 430 units (43 packs of 10) were distributed nationwide to the following states: Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and Canada.
Consumers who have purchased affected cartridges (Lot C6637) should stop using them and contact the manufacturer or their medical provider. The cartridges may not function as intended due to the defective valve.
The recalled product
- Product
- Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
- Manufacturer
- New Medical Technologies Gmbh
- Hazard
- valve-malfunction
- equipment-failure
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 (4)
- Model: C-CA-23
- Item: 33516
- UDI-DI: 10381780171959
- Lots: C6637.
Distribution
Distributed nationwide across the United States.
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