FDA Device recall Z-1104-2025
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517 by New Medical Technologies, citing during the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1104-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-19 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | New Medical Technologies |
| Distribution | US |
Product
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
Reason
During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
Identifiers
| code_info | Model: C-CA-23; Item: 33517; UDI-DI: 10381780171966; Lots: C6741, D0122, D2560 and C6637. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1104-2025%22
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