Fresenius Medical Care recalls 2M dialysis devices over toxin exposure risk [Yahoo! Finance]
Outset Medical, Inc. (OM)
Company Research
Source: Yahoo! Finance
The company will correct its instructions for the devices, warning that patients who weigh under 40 kilograms (about 88 pounds) could be exposed to more than allowable levels of a toxic compound with use of the products. The Class I recall covers almost 2.2 million extension sets and adapters, according to a Thursday recall notice posted by the Food and Drug Administration. The devices have silicone tubes that can expose patients to non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA). The agency noted that the recall does not require product removal. The FDA shared news of the action, which is the latest in a series of steps to mitigate the risks of NDL-PCBAs, alongside details of Outset Medical's recall of its Tablo hemodialysis system. Dive Insight: The FDA wrote to healthcare providers in 2022 to warn about the potential for some Fresenius Medical Care hemodialysis systems to expose patients to NDL-PCBAs and NDL polychlorinated biphenyls (PCBs). Fresenius Medical Car
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News
- Outset Medical Reports First Quarter 2024 Financial ResultsBusiness Wire
- Outset Medical's TabloCart with Prefiltration Receives FDA 510(k) Clearance [Yahoo! Finance]Yahoo! Finance
- Outset Medical's TabloCart with Prefiltration Receives FDA 510(k) ClearanceBusiness Wire
- Outset Medical to Present at Upcoming Investor Conferences [Yahoo! Finance]Yahoo! Finance
- Outset Medical to Present at Upcoming Investor ConferencesBusiness Wire
OM
Earnings
- 5/8/24 - Beat
OM
Sec Filings
- 5/8/24 - Form 8-K
- 5/6/24 - Form 8-K
- 4/11/24 - Form DEFA14A
- OM's page on the SEC website