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Richard Wolf GmbH · Model 8518031 · UDI-DI 04055207017906
9
510(k) clearances
38
Adverse events (2 deaths)
25
Recalls
37
Facilities
Description
GUIDE SLEEVE WL 92MM for suprapubic aspiration set for introduction of a suprapubic balloon catheter following TUR, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
| 2022-02-22 | Busse Hospital Disposables, Inc. | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce |
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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.