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Gyrus ACMI
Gyrus ACMI, LLC · Model 332S8 · UDI-DI 00821925004405
KOA
Prescription
10
510(k) clearances
37
Adverse events
6
Recalls
114
Facilities
Description
Flexible Cystoscopic Foreign Body Forceps, Single-Action, Stem Only 8 Fr (2.7 mm) 35 cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-04-01 | Aesculap Implant Systems LLC | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2020-04-01 | Aesculap Implant Systems LLC | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2019-04-10 | Uromedica Inc. | Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT i |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
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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.