Integra Miltex Cryosolutions Cartridges Recalled for Premature Valve Opening
The Integra Miltex Cryosolutions Cartridges (Model C-CA-23) are being recalled because the valve may open prematurely during assembly, causing the cartridge to empty before use. Approximately 3,352 units were distributed nationwide in the US and 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 a Class II FDA medical device recall with no reported illnesses or injuries. The defect is a functional malfunction (premature valve opening) that prevents the product from working as intended, rather than a direct hazard causing harm.
Plain-English summary
The recalled product is the Integra Miltex Cryosolutions Cartridges 4 Pack (Model C-CA-23, Item 33517), which contains nitrous oxide (N2O) cartridges used in cryosurgical applications. Approximately 3,352 units (838 packs of 4) were affected.
During assembly of the cartridge to its connecting body part, the valve may open prematurely, resulting in partial or complete emptying of the cartridge contents before its intended use. This defect prevents the product from functioning as intended.
The recalled cartridges were distributed nationwide in the United States and Canada. Lot numbers affected are: C6741, D0122, D2560, and C6637 (UDI-DI: 10381780171966).
Healthcare facilities and professionals who have these cartridges should immediately stop using them and contact their supplier for replacement or additional information regarding this recall.
The recalled product
- Product
- Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
- Manufacturer
- New Medical Technologies Gmbh
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 (6)
- Model: C-CA-23
- Item: 33517
- UDI-DI: 10381780171966
- Lots: C6741
- D0122
- D2560 and C6637.
Distribution
Part of a larger recall action
This product is one of 2 recalled by New Medical Technologies Gmbh 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.
See all 2 products in this recall →Related recalls
Same manufacturer · New Medical Technologies Gmbh
See all →- ModerateNitrous Oxide Cartridges Recalled Due to Premature Valve Opening
FDA (Devices) · 2025-02-12
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