MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC · Model 1436 · UDI-DI 00815160021020
Description
A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-21 | Medline Industries, LP | Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortnes |
| 2018-07-11 | POM Medical LLC | Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a clogged port. |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | 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 |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc | |
| 2017-05-10 | ConvaTec, Inc |
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