Vaprox
VAPROX HC Sterilant is 59 percent Hydrogen Peroxide, designed specifically for use in the V-PRO Low Temperature Sterilization Systems. The cup carries RFID tag. Net contents 3 -113 mL per…
VAPROX HC Sterilant is 59 percent Hydrogen Peroxide, designed specifically for use in the V-PRO Low Temperature Sterilization Systems. The cup carries RFID tag. Net contents 3 -113 mL per cup.
2manufacturers in China registered for this device type
4catalogue numbers in this listing
20510(k) clearances naming this product code
11recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Incote Precision Machinery Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 2 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | MLR |
| Device type | Sterilizer, Chemical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6860 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K062297 |
| Record published | 2016-09-08 |
| Record revised | 2024-11-08 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep upright and away from open flame.; Storage environment temperature 15 to 30 °C; Storage environment humidity 0 to 65 % RH |
| Packaging | Case of 3, case of 4 |
| Distribution end date | 2024-11-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PB007 | In distribution | |
| PB012 | In distribution | |
| PB011 | In distribution | |
| PB028 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trilogy® | Zimmer, Inc. | 274 |
| Sterrad™ | Advanced Sterilization Products Services Inc. | 18 |
| NexGen® | Zimmer, Inc. | 15 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 10 |
| V-PRO | Steris Mexico, S. de R.L. de C.V. | 7 |
| Amsco V-PRO | Steris Mexico, S. de R.L. de C.V. | 6 |
| SteroScope Insert Connector Large Assembly, Type 3, Qty 1 | Ideate Medical | 4 |
| Sterilink™ | Plasmapp Co., Ltd. | 3 |
| SteroScope Insert Connector Extra Small Assembly, Type R2, Qty 1 | Ideate Medical | 2 |
| Sterlink™ | Plasmapp Co., Ltd. | 2 |
| SteroScope Biopsy Connector Assembly, Type R1, Qty 1 | Ideate Medical | 2 |
| Sterrad NX™ | Advanced Sterilization Products Services Inc. | 2 |
Showing 12 of 34. All products under Sterilizer, Chemical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233065 | 2023-10-20 |
| K223476 | 2023-08-07 |
| K222093 | 2022-09-09 |
| K190917 | 2019-05-09 |
| K190103 | 2019-04-05 |
| K182568 | 2019-01-03 |
| K172754 | 2018-02-09 |
| K172319 | 2018-01-18 |
| K162413 | 2017-03-31 |
| K160433 | 2016-07-06 |
| K140498 | 2014-07-24 |
| K131120 | 2013-07-16 |
| K120632 | 2012-06-26 |
| K112813 | 2011-12-01 |
| K112760 | 2011-11-22 |
| K111810 | 2011-09-02 |
| K102394 | 2011-08-18 |
| K102330 | 2011-08-12 |
| K083097 | 2009-08-03 |
| K062297 | 2007-10-04 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Steris Corporation | 510(k) number | 2018-07-26 | Class II | Software design | There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run. | 2889 units | 2020-03-30 |
| Steris Corporation | 510(k) number | 2017-09-28 | Class II | Device Design | Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle. | 406 | 2018-09-12 |
| Steris Corporation | 510(k) number | 2011-08-01 | Not classified | Other | STERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the device’ | 663 units | 2013-03-27 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2013-11-21 | Class II | Device Design | Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts. | 6,028 units | 2014-06-16 |
| 2012-07-03 | Class II | Nonconforming Material/Component | STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges. | 629 cards | 2013-03-27 |
| 2011-08-11 | Not classified | Other | STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system. | 2,235 units | 2013-03-19 |
| 2010-07-02 | Not classified | Other | Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced. | 936 | 2012-09-27 |
| 2003-04-23 | Not classified | Other | The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process. | 354 units | 2004-02-05 |
| 2003-04-23 | Not classified | Other | The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process. | 138 units | 2004-02-05 |
| 2003-03-20 | Not classified | Other | The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope. | 46 | 2004-02-05 |
| 2003-03-07 | Not classified | Other | The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle. | 1,140 units | 2004-02-05 |
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.