Z-1104-2025 Class II Ongoing

Recalled by New Medical Technologies Gmbh — Bern

Recall Details

Product Type
Devices
Report Date
February 12, 2025
Initiation Date
December 19, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,352 units (838 packs of 4)

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.

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.

Code Information

Model: C-CA-23; Item: 33517; UDI-DI: 10381780171966; Lots: C6741, D0122, D2560 and C6637.