Home › Device types › MLR
Sterilizer, Chemical
FDA product code MLR · Class 2 · General Hospital
635
Registered devices
5,242
Adverse events
46
Recalls
47
510(k) clearances
Devices with this code
Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.NexGen® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.STERRAD™ — ADVANCED STERILIZATION PRODUCTS SERVICES INC.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.Trilogy® — Zimmer, Inc.
Recent 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 ex |
| 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 beco |
| 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 enclos |
| 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 func |
| 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 func |
| 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 func |
| 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 o |
| 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 S4 |
| 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 |
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