FDAClass IIFebruary 12, 2025

Integra Miltex CryoSolutions Cartridges 10 Pack recall

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

Why was Integra Miltex CryoSolutions Cartridges 10 Pack 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: C-CA-23; Item: 33516; UDI-DI: 10381780171959; Lots: C6637.

Product
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Recalling firm
New Medical Technologies Gmbh
Quantity
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.
Recall date
February 12, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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