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Richard Wolf GmbH · Model 851804 · UDI-DI 04055207010570

FBQ
9
510(k) clearances
38
Adverse events (2 deaths)
25
Recalls
37
Facilities

Description

STABILISATION DISC Ø 5.5MM 86MM Length 152mm, reusable

Recalls

DateFirmReason
2022-02-22Busse 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
2022-02-22Busse 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
2022-02-22Busse 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
2022-02-22Busse 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
2022-02-22Busse 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
2022-02-22Busse 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
2022-02-22Busse 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
2022-02-22Busse 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
2022-02-22Busse 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
2022-02-22Busse 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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Data 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.