FDA (Devices) recall action 88270
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
There is a potential for internal leaks within catheters.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks that could affect proper device function.
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.
Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit (REF: XT3515KTP) due to potential for internal leaks. The recall affects 70 units distributed across the US and internationally.
Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.
Edwards Lifesciences is recalling its PediaSat Oximetry Catheter Set due to potential for internal leaks within the device.
Edwards Lifesciences recalls PediaSat Oximetry Catheter Kits (REF: XT3515SP) due to potential for internal leaks that could affect oxygen saturation monitoring.