Device product
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Z-1103-2025
Product summary
- Event
- Event 96067
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 430 units (43 packs of 10)
- Official record key
device-enforcement:Z-1103-2025
Official wording
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.
Code information: Model: C-CA-23; Item: 33516; UDI-DI: 10381780171959; Lots: C6637.
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.
Derived failure modes
-
Unknown
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.