Z-1104-2025Class II

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517

Name: Z-1104-2025 Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517
Creator: New Medical Technologies Gmbh
Published: 2024-12-19
License: https://open.fda.gov/license/

New Medical Technologies GmbH / initiated 2024-12-19 / Open, Classified / root cause: design

FDA source

New Medical Technologies Gmbh began a recall of Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517 on 2024-12-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1104-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-19
Posted: 2025-02-05
Recalling firm: New Medical Technologies GmbH
Product: Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
Product code: GEH Unit, Cryosurgical, Accessories
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.
Root cause tag: design
FDA 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 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: 3,352 units (838 packs of 4)
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 codes and lots: Model: C-CA-23; Item: 33517; UDI-DI: 10381780171966; Lots: C6741, D0122, D2560 and C6637.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1104-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1103-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05
Z-1104-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-05

Product code GEH

K091721Class IICryosuccess, Model C-Suc-01, C-Suc-02, C-Dts-02, C-Dts-03, C-Gts-13. C-Ca-23New Medical Technologies GmbH / cleared 2009-10-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)