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Silicone Drainage Tube
FORTUNE MEDICAL INSTRUMENT CORP. · Model 60-010020 · UDI-DI 04710961937814
10
510(k) clearances
886
Adverse events (10 deaths)
23
Recalls
213
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-03-27 | Galt Medical Corporation | Due to a potential open seal in the sterile barrier packaging . |
| 2020-11-16 | Galt Medical Corporation | Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle. |
| 2019-05-02 | Cook Inc. | The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product. |
| 2018-05-04 | Vascular Solutions, Inc. | The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxi |
| 2018-05-02 | Galt Medical Corporation | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bact |
| 2018-05-02 | Galt Medical Corporation | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bact |
| 2018-05-02 | Galt Medical Corporation | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bact |
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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.