PlainRecalls
FDA Devices Moderate Class II Ongoing

Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

Reported: February 12, 2025 Initiated: December 19, 2024 #Z-1103-2025

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.

Details

Units Affected
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.
Location
Bern

Frequently Asked Questions

What product was recalled?
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;. Recalled by New Medical Technologies Gmbh. Units affected: 430 units (43 packs of 10).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 12, 2025. Severity: Moderate. Recall number: Z-1103-2025.