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Richard Wolf GmbH · Model 8968015 · UDI-DI 04055207023396
10
510(k) clearances
221
Adverse events
3
Recalls
65
Facilities
Description
DILATOR 15FR for One-Step - Bougie application, TL 320mm, cannulated, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-04 | Cook Inc. | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| 2019-01-04 | Cook Inc. | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| 2005-08-01 | Cook Urological, Inc. | Mislabeled as to size. |
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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.