Recall Z-1103-2025 ยท GEH Unit, Cryosurgical, Accessories
New Medical Technologies Gmbh
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
| Date | Feb 5, 2025 (initiated Dec 19, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On December 19, 2024 "Important Notice Regarding Your Device" letters were sent to customers. Corrective Actions: We have implemented the following corrective and preventive actions to address this issue: 1. Enhanced Testing: All cartridges are now being filled with a minimum specified volume (23.5g tolerance) and subjected to rigorous leakage testing. 2. Updated Specifications: We have revised the interface connection specifications to include precise tolerances and correlated these adjustments with the gas volume requirements. 3. Improved Instructions for Use (IFU): Additional safety preca |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091721 | CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 New Medical Technologies GmbH, Oct 2, 2009 |