Home › Device types › FRG
Wrap, Sterilization
FDA product code FRG · Class 2 · General Hospital
4,214
Registered devices
222
Adverse events
50
Recalls
323
510(k) clearances
Devices with this code
V. Mueller — CAREFUSION 2200, INCV. Mueller — STERIS CORPORATIONAESCULAP — Aesculap AGMedichoice — OWENS & MINOR DISTRIBUTION, INC.Henry Schein — HENRY SCHEIN, INC.CUSTOMED — CUSTOMED INCAESCULAP — Aesculap AGBrasseler USA — Peter Brasseler Holdings, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline — MEDLINE INDUSTRIES, INC.Halyard — OWENS & MINOR DISTRIBUTION, INC.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.Encompass — Encompass Group, L.L.C.ComPel Single Wrap — STANDARD TEXTILE CO., INC.CASE MEDICAL — Case Medical Inc.House Brand Dentistry — Frontier Dental Supply IncAESCULAP — Aesculap AGMedline — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCPATTERSON — PATTERSON DENTAL SUPPLY, INC.Medline — MEDLINE INDUSTRIES, INC.Midway Everyday — MIDWAY DENTAL SUPPLY, LLCV. Mueller — CAREFUSION 2200, INCHalyard — OWENS & MINOR DISTRIBUTION, INC.
Recent 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 po |
| 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 po |
| 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 po |
| 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 pouc |
| 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 po |
| 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 po |
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