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DeRoyal
DEROYAL INDUSTRIES, INC. · Model 71-3009 · UDI-DI 00749756589765
10
510(k) clearances
2,074
Adverse events (55 deaths)
33
Recalls
274
Facilities
Description
Canister Suction 1200cc
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.