Z-1103-2025 Class II Ongoing
FDA device recall Z-1103-2025 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: 430 units (43 packs of 10).
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
- 430 units (43 packs of 10)
Product Description
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
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: 33516; UDI-DI: 10381780171959; Lots: C6637.