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V-PRO
Steris Mexico, S. de R.L. de C.V. · Model 60 · UDI-DI 00724995152000
6
510(k) clearances
5,242
Adverse events (4 deaths)
46
Recalls
24
Facilities
Description
The V-PRO 60 Low Temperature Sterilization System with VAPROX HC Sterilant is a vaporized hydrogen peroxide Sterilizer intended for use in the terminal Sterilization of properly cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare Facilities.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-26 | Steris Corporation | 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 sterila |
| 2017-09-28 | Steris Corporation | Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle. |
| 2017-01-09 | Advanced Sterilization Products | Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during |
| 2015-07-17 | Advanced Sterilization Products | Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypro |
| 2014-11-04 | Advanced Sterilization Products | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after |
| 2014-11-04 | Advanced Sterilization Products | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after |
| 2014-11-04 | Advanced Sterilization Products | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after |
| 2013-12-16 | Advanced Sterilization Products | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possi |
| 2013-11-21 | Steris Corporation | Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solu |
| 2013-11-11 | Advanced Sterilization Products | Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyuretha |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.