Karl Storz
Tecomet · Model KSE09019 · UDI-DI 00817766024924
FRG
Prescription
10
510(k) clearances
222
Adverse events
50
Recalls
194
Facilities
Description
Neonate/Cysto & Resection Tray
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-05 | Turbett Surgical, Inc. | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. |
| 2022-12-05 | Turbett Surgical, Inc. | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. |
| 2022-04-14 | Turbett Surgical, Inc. | Devices were subject to unapproved rework processes. |
| 2022-04-01 | TURBETT SURGICAL, LLC | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. |
| 2020-12-02 | Steris Corporation | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst |
| 2020-12-02 | Steris Corporation | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst |
| 2020-12-02 | Steris Corporation | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst |
| 2020-12-02 | Steris Corporation | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst |
| 2020-12-02 | Steris Corporation | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst |
| 2020-12-02 | Steris Corporation | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst |
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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.