FDA-Device2025-02-12Class II

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

New Medical Technologies Gmbh
Hazard

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.

Sold states
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.
Affected count
3,352 units (838 packs of 4)
Manufactured in
Wankdorffeldstrasse 104, Bern, Switzerland
Products
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1104-2025

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