Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
FDA Recall #Z-1104-2025 — Class II — December 19, 2024
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.
Recalling Firm
New Medical Technologies Gmbh — Bern
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,352 units (838 packs of 4)
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: 33517; UDI-DI: 10381780171966; Lots: C6741, D0122, D2560 and C6637.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated