Home › Device types › FRG
Wrap, Sterilization
FDA product code FRG · Class 2 · General Hospital
4,462
Registered devices
244
Adverse events
50
Recalls
323
510(k) clearances
Devices with this code
Medline — MEDLINE INDUSTRIES, INC.Aira — AIRA, LLCMedline — MEDLINE INDUSTRIES, INC.Hu-Friedy — HU-FRIEDY MFG. CO., LLCVIVIT Supply — Vivit Supply LLCHalyard — O&M HALYARD, INC.Brasseler USA — Peter Brasseler Holdings, LLCSteriking® — Wipak OyDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCSimelo — WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.CARDINAL HEALTH — Cardinal Health 200, LLCBrasseler USA — Peter Brasseler Holdings, LLCHu-Friedy — HU-FRIEDY MFG. CO., LLCMedline — MEDLINE INDUSTRIES, INC.AESCULAP — Aesculap AGMcKesson — MCKESSON MEDICAL-SURGICAL INC.CARDINAL HEALTH — Cardinal Health 200, LLCCSR Wraps, 20" x 20" — Dynarex CorporationRMH3 DENTAL — WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.SPS Medical — SPS Medical Supply Corp.Beesure — ASCEND EAGLE INCORPORATEDMedline — MEDLINE INDUSTRIES, INC.Propper Steri-Wrap III 24"x24" — PROPPER MANUFACTURING COMPANY, INC.Arjo Wiggins Medical, Inc. — STERIMED 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 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 |
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