Class 2 Device Recall Integra Miltex CryoSolutions

• Date Initiated by Firm: December 19, 2024
• Date Posted: February 05, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1103-2025
• Recall Event ID: 96067
• 510(K)Number: K091721
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516
• Code Information: Model: C-CA-23; Item: 33516; UDI-DI: 10381780171959; Lots: C6637.
• FEI Number: 3008252257
• Recalling Firm/ Manufacturer: New Medical Technologies Gmbh; Wankdorffeldstrasse 104; Bern Switzerland
• Manufacturer 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.
• FDA Determined 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 precautions regarding gas leakage during assembly are now clearly highlighted in the Instructions for Use (IFU) provided with the product. We are committed to ensuring these actions eliminate the identified problem and prevent its recurrence. Our quality assurance team will also verify the effectiveness of these measures by closely monitoring product performance and feedback. What You Should Do: " Please ensure that all users review the updated Instructions for Use (IFU) to familiarize themselves with the additional safety measures, including warnings regarding the potential for premature gas leakage during cartridge connection. Aligned with that the gas cylinder shall be quickly screwed into the handpiece. " Please ensure that a new O-ring is assembled into the body part of the handpiece We sincerely apologize for any inconvenience this may cause and appreciate your understanding and cooperation. If you have any questions or require assistance, please do not hesitate to contact our customer service team. on January 31, 2025, URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION letters were sent out to sub-accounts from their sole consignee. What You Should Do (Customers (i.e. Medical Facility, etc.)): 1. Please review the notice from UMP (Appendix 1). 2. Please ensure that you review the updated Instructions for Use (IFU) to familiarize yourselves with the additional safety measures, incl
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEH