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Bemis
BEMIS MANUFACTURING COMPANY · Model 3025 055 · UDI-DI 10073088149609
10
510(k) clearances
2,135
Adverse events (55 deaths)
33
Recalls
274
Facilities
Description
3000CC HIFLOW SUCTION CANISTER KIT WITH AEROSTAT FILTER, FLOAT VALVE SHUTOFF WITH GREEN LID AND PACKAGE OF 18'' (457MM)CONNECTING TUBES
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.