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COOK INCORPORATED · Model G01747 · UDI-DI 00827002017474
FEG
Prescription
10
510(k) clearances
342
Adverse events (5 deaths)
14
Recalls
29
Facilities
Description
Duodenography Catheter Open End
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-18 | Cardinal Health 200, LLC | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214. |
| 2025-09-18 | Cardinal Health 200, LLC | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214. |
| 2024-07-24 | Cardinal Health 200, LLC | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. |
| 2023-12-20 | C.R. Bard Inc | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ |
| 2023-12-20 | C.R. Bard Inc | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ |
| 2023-12-20 | C.R. Bard Inc | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ |
| 2023-12-20 | C.R. Bard Inc | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ |
| 2023-12-20 | C.R. Bard Inc | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ |
| 2023-12-20 | C.R. Bard Inc | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ |
| 2023-12-20 | C.R. Bard Inc | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ |
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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.