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V. Mueller
CAREFUSION 2200, INC · Model GU6358 · UDI-DI 10885403128264
FFL
Prescription
10
510(k) clearances
6,077
Adverse events (5 deaths)
10
Recalls
104
Facilities
Description
Pfister-Schwartz Stone Retriever, 6-Wire Basket, With Filiform Tip
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-06-22 | Wilson-Cook Medical Inc. | Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical litho |
| 2023-06-22 | Wilson-Cook Medical Inc. | Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical litho |
| 2022-02-07 | Philips North America, LLC | Update to instructions for use regarding the cleaning and disinfection process for the reusable probes. |
| 2014-10-07 | C.R. Bard, Inc. | The product is non-sterile. |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e |
| 2005-12-20 | Boston Scientific Corp | The basket wire assembly may detach from the drive wire while in the patient. |
| 2005-12-20 | Boston Scientific Corp | The basket wire assembly may detach from the drive wire while in the patient. |
| 2004-10-27 | Cardinal Health | The dispenser box was mislabeled with the wrong length and the wrong wire gauge. |
| 2003-12-22 | C.R. Bard, Inc., Urological Division | Product packaging may contain holes compromising sterility. |
| 2003-12-22 | C.R. Bard, Inc., Urological Division | Product packaging may contain holes compromising sterility. |
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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.