GlobeNewswire News Room·2025-05-05 16:47Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning letter from the FDA regarding unauthorized changes to its infusion pump products [1][3]. Group 1: FDA Warning and Impact - On April 22, 2025, ICU disclosed that it received a warning letter from the FDA, which cited unauthorized modifications to two of its infusion pump products, labeling them as "adulterated" and "misbranded" [3]. - The FDA's letter indicated that these modifications could significantly affect the functionality of the devices, particularly concerning the infusion delivery profile and alarm functionality, raising safety and efficacy concerns [3]. - Following the news of the FDA warning, ICU's stock price dropped by $6.04 per share, or 4.42%, closing at $130.68 per share on the same day [4]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of ICU investors regarding potential securities fraud or other unlawful business practices by the company and its officers or directors [1]. - Investors are encouraged to contact Pomerantz LLP for more information about the class action [2]. Group 3: Pomerantz LLP Background - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of recovering significant damages for victims of securities fraud and corporate misconduct [5].