Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Summary
The FDA issued a Class II for Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23 by New Medical Technologies Gmbh. 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 cart.
Details
Source
Device Recall
External ID
Z-1103-2025
Action Date
2025-02-12
Status
Ongoing
Category
device
Product Description
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Lot/Code Info: Model: C-CA-23; Item: 33516; UDI-DI: 10381780171959; Lots: C6637.
Quantity Affected: 430 units (43 packs of 10)
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-19
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
New Medical Technologies Gmbh has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (New Medical Technologies Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does New Medical Technologies Gmbh have FDA actions?
New Medical Technologies Gmbh has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1103-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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