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Recall Observatory FDA recall evidence

Device product

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

Z-1104-2025

December 19, 2024

Class II

Product summary

Firm
New Medical Technologies Gmbh
Event
Event 96067
Status
Ongoing
Classification
Class II
Quantity
3,352 units (838 packs of 4)
Official record key
device-enforcement:Z-1104-2025

Official wording

Reason: 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.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.