Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
FDA Recall #Z-1103-2025 — Class II — December 19, 2024
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.
Recalling Firm
New Medical Technologies Gmbh — Bern
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
430 units (43 packs of 10)
Distribution
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated