FDA (Devices) recall action 77282
The FDA (Devices) publishes a recall like this one as 18 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 18 pages.
Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
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.
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Oxygen Masks. The recall was initiated due to quality concerns, though no specific defect is described in the source.
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Masks due to a potential defect in the check valve. The recall covers units distributed in the US and internationally.
ConvaTec is recalling elongated oxygen masks because tubing may detach from the connector, potentially disrupting oxygen supply to users.
ConvaTec is voluntarily recalling elongated oxygen masks in the US and 27 other countries. The recall was initiated by the firm and is classified as FDA Class II.
ConvaTec, Inc. is voluntarily recalling specific lots of Adult High Concentration Non-Rebreather Oxygen Masks due to a Class II defect.
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen tubing due to a Class II defect. The recall covers units distributed across the US and multiple international countries.
ConvaTec is recalling specific lots of pediatric oxygen masks because the check valve may not function correctly, potentially affecting oxygen delivery.
ConvaTec, Inc. is voluntarily recalling adult non-rebreather masks with 'No-Crush' tubing. The recall was initiated in May 2017 and is now terminated.
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen masks with tubing. The recall was initiated by the firm and is currently terminated.
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreathing Masks with tubing. The recall is classified as Class II by the FDA.
ConvaTec is recalling specific lots of infant high concentration non-rebreather oxygen masks due to a Class II safety concern.
ConvaTec is voluntarily recalling specific lots of pediatric oxygen masks. The recall addresses a potential defect in the high-concentration rebreather devices.
ConvaTec, Inc. is voluntarily recalling Rebreathing Masks, Reservoir bags, with Tubing (Product Code 104MM) due to a Class II safety concern.
ConvaTec is voluntarily recalling specific lots of adult non-rebreather oxygen masks. The recall was initiated due to quality concerns, with no specific injuries reported in the source text.
ConvaTec is voluntarily recalling specific lots of Rebreather Oxygen Masks. The recall was initiated by the firm and is classified as Class II by the FDA.
ConvaTec is voluntarily recalling specific lots of elongated adult non-rebreather oxygen masks. The recall was initiated in 2017 and is now terminated.
ConvaTec, Inc. is voluntarily recalling specific lots of non-rebreathing masks and reservoir bags because the check valves may fail to function correctly.
ConvaTec is voluntarily recalling specific lots of elongated oxygen masks. The FDA classified this as a Class II recall, indicating a reasonable probability of temporary adverse health consequences.