MADA MEDICAL PRODUCTS, INC.
MADA MEDICAL PRODUCTS, INC · Model 178B · UDI-DI 00815160020511
Description
A cylindrical sealable container typically made of disposable plastic materials used as a component of a suction system, or other system that utilizes suction, and which is designed for the collection of aspirated waste materials (e.g., blood, bodily fluids, rinsing fluids, laser plume evacuation gas) and/or body tissue intended for diagnostic/therapeutic purposes (e.g., histological analysis, autologous fat tissue transfer) from a site of operation. It may be used singularly or in a connected series to provide greater capacity. This is a single-use device that should be appropriately discarded with its contaminated waste content.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-27 | MEDLINE INDUSTRIES, LP - Northfield | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the pote |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2024-03-22 | MEDLINE INDUSTRIES, LP - Northfield | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. |
| 2023-09-05 | Atrium Medical Corporation | Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation |
| 2023-03-01 | Atrium Medical Corporation | The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device |
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