Z-1104-2025 Class II Ongoing
FDA device recall Z-1104-2025 was initiated by New Medical Technologies Gmbh on December 19, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 3,352 units (838 packs of 4).
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2025
- Initiation Date
- December 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,352 units (838 packs of 4)
Product Description
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AR, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA and the country of Canada.
Code Information
Model: C-CA-23; Item: 33517; UDI-DI: 10381780171966; Lots: C6741, D0122, D2560 and C6637.