FDA Device Intelligence
Home › Steris Mexico, S. de R.L. de C.V. › AMSCO V-PRO

AMSCO V-PRO

Steris Mexico, S. de R.L. de C.V. · Model maX · UDI-DI 00724995151997

MLR
10
510(k) clearances
5,242
Adverse events (4 deaths)
46
Recalls
24
Facilities

Description

The Amsco V-PRO maX Low Temperature Sterilization System is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices used in Healthcare Facilities.

Recalls

DateFirmReason
2018-07-26Steris CorporationThere 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
2017-09-28Steris CorporationCorrection to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
2017-01-09Advanced Sterilization ProductsAdvanced 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
2015-07-17Advanced Sterilization ProductsAdvanced 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
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after
2013-12-16Advanced Sterilization ProductsAdvanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possi
2013-11-21Steris CorporationCustomers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solu
2013-11-11Advanced Sterilization ProductsAdvanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyuretha

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.