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STERIS CORPORATION · Model SC1361 · UDI-DI 00724995096151
10
510(k) clearances
228
Adverse events
50
Recalls
194
Facilities
Description
The Steam Filter Cartridge Kit, is used with the Sterilization Container System. It contains 1000 filter cartridges for steam sterilization, 1336 tamper evident devices, and 500 indicator cards.
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.