Revital-Ox
Revital-Ox PAA HLD Solution Part B is used Revital-Ox PAA HLD Part A and the enspire 300 Series Automated Endoscope Reprocessor
1manufacturer
2catalogue numbers in this listing
19510(k) clearances naming this product code
11recalls on this code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | MED |
| Device type | Sterilant, Medical Devices |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6885 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K230560 |
| Record published | 2024-04-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | expiry date, manufacturing date |
| Packaging | Case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4454AW | In distribution | |
| 4453AW | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterilant, Medical Devices | Steris Corporation | 149 |
| Formed Irrigating Cystotomes | Sterimedix Ltd. | 37 |
| Hydrodissection Cannulae | Sterimedix Ltd. | 29 |
| Sterilant, Medical Devices | Corporation Steris Canada | 29 |
| Anterior Chamber Maintenance Cannulae | Sterimedix Ltd. | 17 |
| Anaesthetic Needles | Sterimedix Ltd. | 14 |
| Formed Capsularhexis Cystotomes | Sterimedix Ltd. | 8 |
| Refractive Cannulae | Sterimedix Ltd. | 8 |
| enspire | Corporation Steris Canada | 8 |
| Cidex™ | Advanced Sterilization Products Services Inc. | 8 |
| Bimanual Cannulae and Hand Pieces | Sterimedix Ltd. | 7 |
| Bimanual I/A Systems | Sterimedix Ltd. | 7 |
Showing 12 of 96. All products under Sterilant, Medical Devices
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251666 | 2026-04-08 |
| K232914 | 2023-10-03 |
| K230582 | 2023-03-28 |
| K222615 | 2022-09-28 |
| K211607 | 2021-09-07 |
| K210737 | 2021-05-12 |
| K192929 | 2019-12-10 |
| K191343 | 2019-09-05 |
| K182827 | 2019-01-31 |
| K173256 | 2018-03-02 |
| K170956 | 2017-09-22 |
| K161683 | 2016-08-05 |
| K131078 | 2013-07-05 |
| K113520 | 2012-02-21 |
| K102462 | 2010-09-21 |
| K101409 | 2010-08-02 |
| K091022 | 2010-04-12 |
| K090036 | 2010-04-05 |
| K080420 | 2008-09-02 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-12-04 | Class II | Nonconforming Material/Component | The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions. | 809 units | 2016-08-26 |
| 2013-03-04 | Class II | Labeling Change Control | During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing q | QLC1677E: 38; QRC1699E: 128 & QPC1721E/QFC1683E: 0 | 2013-07-02 |
| 2012-08-10 | Class II | Device Design | STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unava | 64 units | 2013-07-05 |
| 2012-08-01 | Class II | Nonconforming Material/Component | The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property. | 6,051 units | 2014-06-06 |
| 2011-12-07 | Not classified | Software design | Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet thes | 3,882 units were distributed | 2014-05-13 |
| 2011-03-14 | Not classified | Other | The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warnin | 106 units | 2013-03-13 |
| 2008-08-04 | Not classified | Device Design | During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barblock may interfere with the top surface of bottom barb of the adapter. | QPC1713 Quick Connects – 116 units & QPC1724 Quick Connects | 2013-02-26 |
| 2008-02-19 | Not classified | Device Design | Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the Sterile Cycle. The | 28,766 units | 2012-02-24 |
| 2007-09-12 | Not classified | Component design/selection | Loose or missing adaptor: The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor’s housing. The absence of adaptor #6’s center insert may affect the sterilization process of the attached endoscope. | 391 Quick Connects | 2010-09-28 |
| 2007-02-23 | Not classified | Process control | The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope | 146 | 2012-03-01 |
| 2004-03-15 | Not classified | Process control | A defective port adapter may affect the sterilization process of the attached endoscope. | 40 units | 2004-05-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.