Home › Device types › JOJ
Indicator, Physical/Chemical Sterilization Process
FDA product code JOJ · Class 2 · General Hospital
970
Registered devices
444
Adverse events
24
Recalls
265
510(k) clearances
Devices with this code
Britedent — Bright Supply, Inc.LATEX LEAD FREE STEAM TAPE — SPS Medical Supply Corp.Steam Indicator Tape — CROSSTEX INTERNATIONAL, INC.Bionova® — TERRAGENE S.A.JMU — JMU DENTAL, INCPropper Blue Autoclave Indicator Tape — PROPPER MANUFACTURING COMPANY, INC.Nev's Ink Inc. — NEVS INK, INC.MARK3 — CARGUS INTERNATIONAL, INCCintape® — TERRAGENE S.A.Getinge Blue Sterilization Indicator Tape 1" — STERITEC PRODUCT MFG. CO., INC.STEAMPLUS TRAY RECORD CARD — SPS Medical Supply Corp.CARDINAL HEALTH — Cardinal Health 200, LLCSTERILUCENT CHEMICAL INDICATOR LABEL — SPS Medical Supply Corp.Medline — MEDLINE INDUSTRIES, INC.ProChek S — CERTOL INTERNATIONAL, LLCHu-Friedy — HU-FRIEDY MFG. CO., LLCGetinge Assured Tape 18mm (Ethylene Oxide) — STERITEC PRODUCT MFG. CO., INC.MARK3 — CARGUS INTERNATIONAL, INCMARK3 — CARGUS INTERNATIONAL, INCVERIFY — STERIS CORPORATIONGetinge Assure ChemiPack Integrator Test Pack — STERITEC PRODUCT MFG. CO., INC.VERISURE™ — TERRAGENE S.A.MARK3 — CARGUS INTERNATIONAL, INCHEATmarker® Time-Temperature Indicators: F6 — Temptime Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-07 | TERRAGENE S.A. | Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. |
| 2023-04-06 | 3M Company - Health Care Business | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a st |
| 2023-04-06 | 3M Company - Health Care Business | 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a st |
| 2022-08-10 | Steris Corporation Hopkins Facility | Product contains incorrect chemical indicators in packaging. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2021-12-29 | Young Dental Mfg Co I LLC | The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels. |
| 2020-06-17 | Resource Optimization & Innovation LLC | The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use. |
| 2013-12-19 | Steris Corporation | STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522 |
| 2013-06-10 | Steritec Products Mfc. Co., Inc. | Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) b |
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