Recall Z-1104-2025— New Medical Technologies Gmbh

Name: FDA recall Z-1104-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Class II · Ongoing

Class II FDA medical device recall by New Medical Technologies Gmbh, initiated 2024-12-19. It names one FDA 510(k) clearance: K091721. Product: Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;. 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..

Recalling firm: New Medical Technologies Gmbh
Classification: Class II
Status: Ongoing
Initiated: 2024-12-19
Firm location: Bern, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K091721 — CRYOSUCCESS, 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

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.