FDA Medical devices recall ·
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each)… recall
- Recall number
- Z-1103-2025
- Date
- (initiated December 19, 2024)
- Company / brand
- New Medical Technologies Gmbh
Wankdorffeldstrasse 104, Bern, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 430 units (43 packs of 10)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model: C-CA-23; Item: 33516; UDI-DI: 10381780171959; Lots: C6637.
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.
States: Arkansas California Colorado Florida Georgia Illinois Indiana Kentucky Louisiana Massachusetts Maryland Minnesota Missouri North Carolina Nebraska New Jersey Nevada New York Ohio Pennsylvania South Carolina Tennessee Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1103-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.