Integra Miltex recallZ-1103-2025 · New Medical Technologies Gmbh · initiated Dec 19, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from New Medical Technologies Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-1103-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 19, 2024
- Posted by the FDA
- Feb 5, 2025
- Recalling firm
- New Medical Technologies Gmbh
- Quantity
- 430 units (43 packs of 10)
- Product code
- GEH
- FDA submissions
- K091721
- 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.
Product description
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
Code information (models, lots, serial numbers)
Model: C-CA-23; Item: 33516; UDI-DI: 10381780171959; Lots: C6637.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Integra® Miltex® 33516Integra Lifesciences Production Corporation · UNIT, CRYOSURGICAL, ACCESSORIES1 recall4 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K091721 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Integra® Miltex® 33517Integra Lifesciences Production Corporation · UNIT, CRYOSURGICAL, ACCESSORIES1 recall17 reports
- Integra® Miltex® 33510Integra Lifesciences Production Corporation · UNIT, CRYOSURGICAL, ACCESSORIES15 reports
- Integra® Miltex® 33518Integra Lifesciences Production Corporation · UNIT, CRYOSURGICAL, ACCESSORIES4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96067).
- Z-1104-2025 · Open, ClassifiedIntegra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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