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Silicone Thoracic Drain, SF Type
FORTUNE MEDICAL INSTRUMENT CORP. · Model 2018-0136 · UDI-DI 14710961936166
10
510(k) clearances
32
Adverse events
20
Recalls
40
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-08-10 | Atrium Medical Corporation | Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters. |
| 2010-08-10 | Atrium Medical Corporation | Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters. |
| 2009-02-27 | Concentric Medical Inc | Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing. |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparinc allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
| 2008-05-12 | Atrium Medical Corporation | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate |
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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.